1.
ClinicalTrials.gov; 29/01/2024; TrialID: NCT06231238
Clinical Trial Register
| ICTRP | ID: ictrp-NCT06231238
ABSTRACT
Condition:
Post-COVID-19 Syndrome;Long COVIDIntervention:
Behavioral: Balance Acceptance and Commitment TherapyPrimary outcome:
36-item Short Form Health Survey (SF-36)Criteria:
Inclusion Criteria:
1. Age 18 or older
2. LC/PCS diagnosis as defined by National Health Service (NHS) / National Institute for
Health and Care Excellence (NICE) (i.e., symptoms that develop during or after an
infection consistent with COVID-19, continue for more than 12 weeks and are not
explained by an alternative diagnosis). A checklist will be used to ensure
participants fulfil the diagnostic criteria as per the NICE guidelines
3. Ability to travel to the research site for the study assessments
4. Consent to wear a smartwatch throughout the study
5. Having registered with a General Practitioner (GP) in the United Kingdom (UK) and
consent to provide their details for the study team to contact
6. Ability to provide informed consent
7. Ability to read and write English
Exclusion Criteria:
1. Current diagnosis of an active major mental health disorder likely to interfere with
participation
2. Unstable alcohol / drug dependency
3. Unstable complications associated with LC/PCS
4. Past hospitalisation for COVID-19
5. Current or recent participation in other treatment intervention studies (<4 weeks
after completion)
6. Currently receiving psychological support or psychotherapy
7. Implanted medical devices (ie., Pacemaker/defibrillator or implanted
neurostimulator/infusion device; implanted metal objects; artificial hip/knee
replacement, spinal surgery; cardiac surgery requiring the placement of metal clips,
valves or wires)
8. Pregnancy
2.
ISRCTN; 16/10/2023; TrialID: ISRCTN52834682
Clinical Trial Register
| ICTRP | ID: ictrp-ISRCTN52834682
ABSTRACT
Condition:
Post-Traumatic Stress Disorder (PTSD)Mental and Behavioural Disorders
Intervention:
We are using a novel therapy called Fast Imagery Reversal Script for Trauma-release (FIRST) which is a possible new treatment for PTSD. FIRST draws on NLP (neurolinguistic programming) approaches and reconsolidation processes to deliver a therapy in which the person is asked to visualise in a way that is intended to be comfortable, non-traumatising, and non-intrusive. At no point is the person asked to describe the detail of the experiences that lead to their PTSD. The treatment is offered in up to four weekly individual session of 90 minutes duration.As well as completion at baseline, participants will be asked to complete a series of questionnaires at completion of the FIRST therapy and at four weeks after their last FIRST session.
Participants will also be asked to take part in an exit interview for which they will have provided informed consent.
Interviews will last approximately 45 minutes and will take place online (via Microsoft Teams).
Primary outcome:
To understand the feasibility and acceptability of FIRST therapy for HSCWs and MHPs. Feasibility and acceptability will be assessed via the qualitative exit interviews and will answer these questions:1. Will HSCWs present for, commence and complete FIRST therapy.
2. Do HSCWs find FIRST therapy and referral processes acceptable.
3. Do they find the proposed outcome measures acceptable to consent to and complete?
4. Are research procedures acceptable?
5. How do the therapists (MHPs) experience (i) delivering FIRST and (ii) to HSCWs colleagues.
The exit interviews will take place at four weeks’ post end-of-therapy delivery and qualitative content analysis will be applied to the data.
Criteria:
Inclusion criteria: 1. Adults > = 18 years2. Working in NHS Trusts, Primary Care or Social Care between 1st March 2020 and 31st March 2021 covering the three UK waves of the pandemic.
3. Prior, or new, diagnosis of PTSD determined by a PCL-5 score > 32. Confirmed by the Staff Counselling and Wellbeing Service or Post-Incident Pathway, within SLaM.
Exclusion criteria: 1. Currently receiving psychological treatment for PTSD.
2. Not able to provide informed consent.
3. Unwilling to consent to video-recording of therapy sessions for supervisory purposes.
3.
ClinicalTrials.gov; 02/10/2023; TrialID: NCT06072287
Clinical Trial Register
| ICTRP | ID: ictrp-NCT06072287
ABSTRACT
Condition:
Asthma;Atrial Fibrillation;Cancer;Cerebrovascular Disorders;Stroke;CKD;Copd;Fibromyalgia;Pain;Heart Diseases;Heart Disease Chronic;Dementia;Diabetes;Epilepsy;Heart Failure;High Blood Pressure;Hypertension;Hiv;AIDS;IBD;IBS;Liver Diseases;Long COVID;Lupus Erythematosus;Multiple Sclerosis;Obesity;Osteoarthritis;Arthritis;Rheumatoid Arthritis;Osteoporosis;Parkinson Disease;Sickle Cell Disease;Hepatitis;Endometriosis;PCOS;Neurological Disorder;POTS - Postural Orthostatic Tachycardia Syndrome;MND (Motor Neurone DIsease);Cystic Fibrosis;Migraine;Spondylitis;Celiac Disease;Hidradenitis Suppurativa;Eczema;ME/CFSIntervention:
Diagnostic Test: Living with LTC QuestionnairePrimary outcome:
Illness-related distressCriteria:
Inclusion Criteria:
- Over the age of 18
- Self-reported diagnosis of a Long-Term Condition
- UK resident
- Possession of an email address to enable all study procedures
- Sufficient command of written and spoken English to understand study procedures
Exclusion Criteria:
- Under the age of 18
- Not living in the UK
- No self-reported diagnosis of an LTC
- Inability to complete questionnaires in English
4.
ClinicalTrials.gov; 21/08/2023; TrialID: NCT06011135
Clinical Trial Register
| ICTRP | ID: ictrp-NCT06011135
ABSTRACT
Condition:
Chronic Fatigue SyndromeIntervention:
Other: No interventionPrimary outcome:
Exploration of how people with a diagnosis of CFS/ME experience worry;How can this exploration of how people with a diagnosis of CFS/ME experience worry inform future research into targeted CBT interventions in the context of ME/CFS.Criteria:
Inclusion Criteria:
- have a diagnosis of ME/CFS according to NICE criteria;
- have agreed to CBT for ME/CFS following their initial assessment;
- are/were struggling with comorbid generalised worry as determined by a score of 45 or
above on the Penn State Worry Questionnaire (collected routinely with all patients
referred to the service).
- Informed consent to taking part in the study
Exclusion Criteria:
- Patients who have been closed to the service longer than 3 months
- Patients with a diagnosis of long-Covid
- Patients who are under 18
- Patients who do not have a diagnosis of CFS/ME
- Patients who have not agreed to CBT for CFS/ME as part of their treatment
- Patients who score below the threshold on the PSWQ
5.
ClinicalTrials.gov; 17/08/2022; TrialID: NCT05515263
Clinical Trial Register
| ICTRP | ID: ictrp-NCT05515263
ABSTRACT
Condition:
Immune ResponseIntervention:
Dietary Supplement: Intervention snack;Dietary Supplement: Control snackPrimary outcome:
Rates of seroconversion for =1 influenza virus strainCriteria:
Inclusion Criteria:
1. Men or women, aged between 40-64 years
2. Body mass index (BMI) of 18.50 - 29.99 kg/m2
3. Individuals who regularly consume snacks (=2 per day, excluding fruit, vegetable, nut
and seed snacks)
4. Fibre intake <30 g/d
5. Willing to avoid receiving any vaccination (except for COVID-19 vaccination) from one
month prior to the baseline visit until completion of the 8-week intervention period
6. Willing to avoid receiving any COVID-19 vaccination/booster between week 2 and week 8
of the intervention period
7. Willing to discontinue use of prebiotics and probiotics during the trial
8. Willing to follow the protocol and provide consent
Exclusion Criteria:
1. Allergy or intolerance to any intervention products
2. Dislike of any intervention products
3. Immunodeficiency/immunosuppression due to disease or medication, such as:
- Chronic inflammatory disease or autoimmune disease (e.g., rheumatoid arthritis,
inflammatory bowel disease, psoriasis) or primary or secondary immunodeficiency
disease (e.g., HIV infection)
- Ongoing therapy with immunomodulators or immunosuppressants (e.g., chemotherapy,
oral corticosteroids, daily use of inhaled or nasal corticosteroids)
- Other immunodeficient state (e.g., asplenia).
4. Medical history of any of the following: diabetes, major active psychiatric conditions
(e.g. schizophrenia), current eating disorder, alcohol abuse, active treatment for
cancer in the last year, severe neurological, endocrine, renal, cardiac or pulmonary
disease (or any other chronic medical condition), severe oesophagitis, gastritis or
duodenitis, active diverticulitis or intestinal/colonic strictures, Coeliac disease,
Crohn's disease or Ulcerative colitis, stem cell or organ transplant, gut resection
surgery, bleeding disorder, anaphylaxis or any other major or chronic condition known
to impact study outcome measures.
5. Ongoing use of antiviral agents, or any other drugs known to impact study outcome
measures
6. Use of immunoglobulins and/or any blood products within the three months prior to
vaccination
7. Ongoing use of anticoagulants (e.g., warfarin)
8. Antibiotic treatment in the month prior to the start of the study
9. Consumption of probiotics or prebiotic products within the four weeks prior to the
start of the study
10. History of severe adverse reaction and/or allergic reaction associated with the
influenza vaccine or any other vaccine
11. Known allergy or hypersensitivity to any component of the vaccine including: sodium
chloride, potassium chloride, magnesium chloride hexahydrate, disodium phosphate
dihydrate, potassium dihydrogen phosphate; and possible trace residues:
beta-propiolactone, cetyltrimethylammonium bromide, and polysorbate 80
12. Suffered from influenza illness in the six months prior to the start of the study
13. For participants recruited on or before 30/06/2023, exclusion criteria is: already
vaccinated with any influenza vaccine licensed for the 2022/2023 season; For
participants recruited after 30/06/2023, exclusion criteria is: already vaccinated
with any influenza vaccine licensed for the 2023/2024 season
14. Received any influenza vaccination within six months prior to the start of the study
15. Received any other vaccinations within one month prior to the start of the study
(except for COVID-19 vaccination)
16. Women who are pregnant, lactating or planning pregnancy
17. Ongoing alcohol, drug or medication abuse
18. Unexplained or unintentional weight loss in the past six months
6.
ClinicalTrials.gov; 24/01/2022; TrialID: NCT05212766
Clinical Trial Register
| ICTRP | ID: ictrp-NCT05212766
ABSTRACT
Condition:
COVID-19;Microbial Colonization;Oral Disease;Periodontal Diseases;Innate Inflammatory Response;Mucosal InfectionIntervention:
Biological: COVID infection;Biological: COVID vaccination;Diagnostic Test: Oral examinationPrimary outcome:
Relationship between oral mucosal immunity and microbiome on COVID outcomes in different ethnic groupsCriteria:
Inclusion Criteria:
- • South Asian and White British persons and those diagnosed with symptomatic or
asymptomatic COVID-19 infection.
- Aged 18 or over. Able to understand and consent.
- Uninfected subjects: no history of COVID-19; not vaccinated; (negative for
anti-SARS-CoV2 nucleoprotein antibodies at lab)
- For patient groups: Confirmed COVID-19 positivity, symptoms and symptom onset
within the past 21 days; Be recently hospitalised with COVID-19 disease; Have
COVID-19 disease proven by PCR testing for SARS-CoV-2 within the last 21 days;
COVID disease severity graded as per NIH/WHO.
- Recovered groups: Have had COVID-19 disease proven by PCR testing for SARS-CoV-2.
COVID disease severity graded as per WHO or NIH equivalent criteria
- Those willing to participate on a single occasion but unwilling to participate
with longitudinal samples will not be excluded.
- Smoking, obesity, diabetes, heart disease, antibiotics or treatment related to
COVID is not excluded.
Exclusion Criteria:
- • Those patients unwilling to participate, those unable to understand sufficiently to
give informed consent and those unable to participate due to the severity of COVID-19
disease. Those patients classified as not either South Asian or White British
heritage.
- Patients with malignancy, pregnancy, long term immune suppression, inability to
give informed consent, not willing or able to have oral examination.
- Diabetes not excluded but screening for diabetes will be performed: glucose will
be assessed in blood/serum sample (150ul).
Exclusion criteria summary:
- Critically ill participants who cannot give informed consent
- Those who are not willing to have an oral examination, or donate blood or saliva
samples.
- Those who cannot chew / drool to provide a SWMF sample due to severe/critical medical
conditions
- Participants with known malignancies or who are pregnant
- Participants who are on long-term immunosuppressants (e.g. for autoimmune diseases)
- Participation in other current research that is designed to, or is expected to alter
the immune response.
- Inability to communicate, understand or read English.
7.
ISRCTN; 09/09/2021; TrialID: ISRCTN13202325
Clinical Trial Register
| ICTRP | ID: ictrp-ISRCTN13202325
ABSTRACT
Condition:
Sleep quality in children with rolandic epilepsyNervous System Diseases
Epilepsy
Intervention:
CASTLE Sleep-E is a randomised controlled trial comparing an online sleep behaviour intervention against standard care in children with epilepsy.
There is a target recruitment of 110 participants in total. Participants will be children with RE in the UK. All patients aged between 5 and <13 years with diagnosis of RE will be screened at the trial centres to identify potentially eligible participants for the trial. Potentially eligible patients and those providing consent (person with parental responsibility) will be invited to participate in the trial and provided with a patient information sheet and consent form in either an electronic format. There is an option for a paper version of this document to be provided for review, however ultimately all consent/assent for the study will be obtain electronically.
The patient and the person providing consent will be allowed sufficient time to discuss the trial and decide whether to consent/assent to trial entry.
The trial will be open to recruitment for 12 months. Participants will be followed up at 3 and 6 months after randomisation.
At visit 1 (T-4 weeks), a review of medical history and EEG results will be completed. An assessment of the patient against the eligibility criteria will be performed and full eligibility will be confirmed. If the patient is eligible for the study, consent and assent (if the child is 7 years or older and capable) will be sought.
Patient demographics will be collected and a COVID screener questionnaire will also be completed at this visit. Additionally, families be asked to consider taking part in the interview component of the trial, however this is optional and declining to this activity will not i
Primary outcome:
1. Total child sleep problem score as measured by the Child Sleep Habit Questionnaire at baseline and 3 months.
2. Cost utility of COSI reported as incremental cost per QALY gained will be measured using the EQ-5D-Y, CHUD-9D, Resource Use Questionnaire, study visits CRFs, concomitant medications, serious adverse events and utility questionnaires at baseline, 3, and 6 months. PLICS and HES data will be used at the end of trial.
Criteria:
Inclusion criteria:Current inclusion criteria as of 31/01/2023:
Main CASTLE Sleep-E study:
1. Children with clinician-confirmed diagnosis of epilepsy
2. Aged >=4 years and <13 years at the time of randomisation
3. Parent/Carer reported child sleep problem as defined by mild, moderate or severe score on Hiscock Australian global sleep question (Poor sleeper defined by caregiver responding ‘Mild’, ‘Moderate’ or ‘Severe’ to “Over the last 2 weeks, how much of a problem has your child’s sleep been?”)
4. Documented informed consent received from a person with parental responsibility
5. Family have an email address and mobile phone
6. Parent and child are to have a good enough understanding of the English language to read and answer study questionnaires
In order to participate in the Qualitative Component of the study, the following criteria must be met:
1. Consent of caregiver to participate and for their child to participate (optional item on main trial consent form)
2. Children need to be >=7 years of age
Previous inclusion criteria:
Main CASTLE Sleep-E study:
1. Children diagnosed with RE/CECTS (see International League Against Epilepsy Diagnostic Manual at https://www.epilepsydiagnosis.org/syndrome/ects-overview.html)
2. EEG showing focal sharp waves with normal background (see International League Against Epilepsy Diagnostic Manual at https://www.epilepsydiagnosis.org/syndrome/ects-eeg.html)
3. Aged >=5 years and <13 years at the time of randomisation
4. Parent/Carer reported child sleep problem as defined by mild, moderate or severe score on Hiscock Australian global sleep question (Poor sleeper defined by caregiver responding ‘Mild’, ‘Moderate’ or ‘Severe’ to “Over the last 2 weeks, how much of a problem has your child’s sleep been?”)
5. Documented informed consent received from a person with parental responsibility
6. Family have an email address and mobile phone
7. Parent and child are to have a good enough understanding of the English language to read and answer study questionnaires
In order to participate in the Qualitative Component of the study, the following criteria must be met:
1. Consent of caregiver to participate and for their child to participate (optional item on main trial consent form)
2. Children need to be >=7 years of age
Exclusion criteria: Children with moderate/severe learning disabilities
8.
ClinicalTrials.gov; 12/08/2021; TrialID: NCT05009888
Clinical Trial Register
| ICTRP | ID: ictrp-NCT05009888
ABSTRACT
Condition:
HealthyPrimary outcome:
Acceptability of performing antibody testing procedures involving a capillary blood sample collected via finger-prick;Test validity of the antibody tests that are performedCriteria:
Inclusion Criteria:
- King's College Staff member
- Aged 18 years or over
- Able to freely give informed consent
Exclusion Criteria:
The participant may not enter the study if ANY of the following apply:
- known to have an infectious disease including a current SARS-CoV-2 infection.
- Any significant disease or disorder which, in the opinion of the Investigator, may
either put the participants at risk because of participation in the research study, or
may influence the result of the research study, or the participant's ability to
participate in the research study. Examples of disorders or diseases which would be
excluded include:
- Medically diagnosed bleeding disorder;
- Medically diagnosed platelet disorder;
- Anticoagulant medication.
9.
EU Clinical Trials Register; 09/03/2021; TrialID: EUCTR2021-001279-18-Outside-EU/EEA
Clinical Trial Register
| ICTRP | ID: ictrp-EUCTR2021-001279-18-Outside-EUEEA
ABSTRACT
Condition:
Mental Health and Wellbeing of Healthcare Staff;Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]Intervention:
Trade Name: Foundations App - Koa Health
Product Name: Foundations App
Product Code: N/A
Pharmaceutical Form:
Primary outcome:
Main Objective: To evaluate whether the use of Foundations mobile application impacts stress, wellbeing, anxiety, depression, functioning, resilience and sleep in a real-world, high-risk healthcare worker cohort. ;Secondary Objective: Not Applicable;Primary end point(s): 1. The GHQ-12 is a 12-item scale which screens for general (non-psychotic) psychiatric morbidity, (Goldberg et al., 1992).;Timepoint(s) of evaluation of this end point: 4 and 8 weeks (alongside baseline)Criteria:
Inclusion criteria:1. Be aged 18 and over.
2. Be an NHS-affiliated member of staff, working at, or with, the participating eighteen NHS CHECK sites.
3. Completed baseline survey with NHS CHECK Cohort study and have consented to be contacted for further research as part of study.
4. Be able to give informed consent to take part in research.
5. Be able to understand and communicate in English.
6. Have access to the internet to complete the surveys.
7. Have access to an email address to facilitate application registration and receive survey links.
8. Own a smartphone with access to the Apple and Google Application Stores.
The following 18 NHS Trusts have been selected to include a mixture of urban and rural settings:
Avon and Wiltshire Mental Health Mental Health Partnership Trust
Cambridge University Hospitals NHS Foundation Trust
Cambridgeshire and Peterborough NHS Foundation Trust
Cornwall Partnership NHS Foundation Trust
Devon Partnership NHS Foundation Trust
East Suffolk and North Essex NHS Foundation Trust
Gloucestershire Hospitals NHS Foundation Trust
Guys and St Thomas' NHS Foundation Trust
King's College Hospital NHS Foundation Trust
Lancashire and South Cumbria NHS Foundation Trust
Norfolk and Norwich University Hospitals Foundation Trust
Nottinghamshire Healthcare NHS Foundation Trust
Royal Papworth Hospital NHS Foundation Trust
Sheffield Health and Social Care NHS Foundation Trust
South London and Maudsley NHS Foundation Trust
Tees Esk and Wear Valleys NHS Foundation Trust
University Hospitals of Derby and Burton NHS Foundation Trust
University Hospitals of Leicester NHS Foundation Trust
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 650
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50
Exclusion criteria:
1. Plans to start new interventions after randomisation during eight week trial period (e.g. apps, psychological therapies and pharmacological therapies).
10.
ClinicalTrials.gov; 24/02/2021; TrialID: NCT04786080
Clinical Trial Register
| ICTRP | ID: ictrp-NCT04786080
11.
ISRCTN; 20/01/2021; TrialID: ISRCTN17941313
Clinical Trial Register
| ICTRP | ID: ictrp-ISRCTN17941313
ABSTRACT
Condition:
Chronic disease, type 2 diabetes, hypertension, chronic obstructive pulmonary disease, coronary heart diseaseNot Applicable
Intervention:
Current intervention as of 12/06/2023:The intervention involves REaCH training for healthcare workers to deliver remote consulting via mobile phone to patients and will be compared to care as usual. The study will take place in Nigeria (urban/MIC/West Africa) and Tanzania (rural/LIC/East Africa). In each country, 20 primary care facility clusters (each cluster is made up of one or more clinic/facility, which between them has =10 healthcare workers) will be recruited. Tier 1 trainees are healthcare workers with a higher diploma or degree who speak, read and write in English; Tier 2 trainees are other cadres e.g. community health workers, pharmacy assistants, and medical assistants who may communicate in English or in local languages. The tier 1 and tier 2 trainees work as a team within the facility. Health workers will be in the trial for between one and six months depending upon when they receive REaCH training and whether they take part in the process evaluation.
At the beginning of the intervention, all clusters are randomised into groups of two (a sequence) and allocated a monthly timeslot to receive REaCH training over a ten-month period. This will be done by generating a random number for each cluster and then clusters assigned to each sequence in ascending order of the generated number. The randomisation will be conducted by the trial statistician who will be blinded to cluster name. The intervention implementers and clinics will not be blinded to allocation sequence as this is impractical given the need to plan and prepare training. In each local trial delivery team, one investigator and 1 research assistant will remain blinded to the month during which REaCH training was delivered to each cluster. Each facility is given a unique identification number consisti
Primary outcome:
1. Patient trust in healthcare provider measured using the Physician Humanistic Behaviour Questionnaire (PHBQ) at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 months2. Face to face consultation rate defined as the number of visits per month for the eligible patient population where the patient is seen in person by the consulting health worker measured from the open cohort data at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 months
3. Remote consultation rate defined as the number of visits per month for the eligible patient population conducted using a telephone measured from the open cohort data at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 months
4. Prescribing rate defined as the number of prescriptions issued and collected to the eligible patient population per month. This outcome is a proxy for patient safety as a change in this outcome is an indicator of changes in safety and confidence measured from the open cohort data at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 months
Criteria:
Inclusion criteria: 1. Receiving healthcare from participating primary care facilities2. Able to speak, read and write in English or local language
3. Give consent to participate in the study
4. Aged =18 years
5. Receiving treatment and/or monitoring for =1 of the following conditions:
5.1. Type 2 diabetes
5.2. Hypertension
5.3. Chronic obstructive pulmonary disease
5.4. Coronary heart disease
6. Contact with health facility =3 times per year
Exclusion criteria: 1. No access to a mobile phone or fixed phone in the community
2. Identified by health workers as nearing the end of life or currently severely ill
3. Carers consulting on another person’s behalf
4. Unable to provide informed consent
12.
ClinicalTrials.gov; 28/10/2020; TrialID: NCT04636944
Clinical Trial Register
| ICTRP | ID: ictrp-NCT04636944
ABSTRACT
Condition:
Heart Failure;Depression;AnxietyIntervention:
Other: web-based COMPASS interventionPrimary outcome:
Explore community heart failure nurses' perception of assessing, managing and treating depression and anxiety in HF and the use of web-based interventions.;Explore community heart failure patients' perception of assessing, managing and treating depression and anxiety in HF and the use of web-based interventions.;Explore nurses' perception of using web-based COMPASS intervention for depression and anxiety management in HF;Explore patients' perception of using web-based COMPASS intervention for depression and anxiety management in HFCriteria:
Inclusion Criteria:
- Inclusion criteria for Community-based HF patients:
1. Community-based HF patients with clinically established HF diagnosis (confirmed
HF diagnosis) in Lambeth and Southwark Boroughs who have mild to moderate
symptoms of depression with/without anxiety confirmed by PHQ-9 (5-14) and GAD-7;
2. Patients with NYHA class I-III;
3. Capacity to provide informed consent; and
4. Proficiency in English language so can fully respond to verbal and written
material.
Inclusion criteria for Community HF nurses:
1. All community-based HF-nurses employed in Lambeth and Southwark Boroughs who are
registered with Nursing Midwifery Council (NMC) will be invited to participate in the
study;
2. Capacity to provide informed consent;
3. Community HF-nurses who are actively providing care to community-based HF patients;
and
4. have access to internet connected computer or device and technology for Microsoft (MS)
Teams.
Exclusion Criteria:
- Exclusion criteria for community-based HF patients:
1. Community-based HF patients under 18 years of age;
2. Participants who are deemed not to have the capacity to consent;
3. Patients with cognitive impairment or dementia confirmed by medical records; and
4. Community-based HF patients with NYHA class IV.
5. Patients with severe depression and/or having suicidal ideation.
Exclusion criteria for Community HF nurses:
1. Nurses working with inpatients or in the OPD departments; and
2. Nurses who are not employed as community HF nurses.
3. Any community HF nurse who do not have access to internet or online technology.
13.
ISRCTN; 30/09/2020; TrialID: ISRCTN18395399
Clinical Trial Register
| ICTRP | ID: ictrp-ISRCTN18395399
ABSTRACT
Condition:
The psychosocial impact of the COVID-19 pandemic on NHS affiliated staff – monitoring response to the pandemic and the evaluation of local and national staff support programmesMental and Behavioural Disorders
Intervention:
Baseline online survey launched in April 2020 followed by repeated surveys at month 4, 8 and 12. The 4-month survey includes an evaluation of staff support programmes. A subset of participants will also be invited to participate in psychiatric diagnostic interviews between month 4 and month 8.Primary outcome:
General (non-psychotic) psychiatric morbidity, resilience, anxiety, depression, wellbeing, moral injury and burnout measured using online survey at baseline, month 4 and 12Criteria:
Inclusion criteria:1. Affiliated NHS member of staff, working at, or with, the participating NHS Trusts during the COVID-19 pandemic
2. Aged 18 and over
3. Able to give informed consent to take part in research
4. Able to understand and communicate in English
5. Have access to the internet to complete the surveys
6. Have access to an email address to facilitate survey registration and receive survey links
Exclusion criteria:
1. If participants are not an affiliated NHS member of staff, working at, or with, the participating NHS Trusts
2. Aged under 18
3. Unable to give informed consent to take part in research
4. Unable to understand and communicate in English
5. No access to the internet to complete the surveys
6. No access to an email address to facilitate survey registration and receive survey links
14.
ClinicalTrials.gov; 12/08/2020; TrialID: NCT04535778
Clinical Trial Register
| ICTRP | ID: ictrp-NCT04535778
ABSTRACT
Condition:
Treatment of Illness-related Distress in Physical LTCsIntervention:
Behavioral: COMPASS;Behavioral: Standard charity resourcesPrimary outcome:
Change in Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS)Criteria:
Inclusion Criteria:
- Aged 18 or over
- Have responded to sign posting advise from the LTC charity or responded to an advert
placed on a LTC charity website expressing their interest in taking part in the study.
- Speak English to a sufficiently high standard to allow them to interact with digital
CBT programs.
- Live in the UK and can provide contact details of their registered general
practitioner
- Have an email address to allow them to register with a digital CBT program and have a
basic understanding of the internet.
- Scores =3 on the shortened patient health questionnaire (PHQ-4) self-report measure of
depression and anxiety in relation to their LTC and/or the COVID-19 pandemic.
Exclusion Criteria:
- Evidence of alcohol and/or drug dependency, cognitive impairment, severe mental health
disorders, including bipolar disorder or psychosis
- Acute suicidal risk requiring a level of support that cannot be provided by therapists
who are supporting patients remotely in their use of digital health interventions.
- Receiving active psychological treatment. Active psychological treatment is defined as
receiving treatment from a psychologist/counselor/therapist or engaging with other
online psychological treatment interventions.
15.
ISRCTN; 27/07/2020; TrialID: ISRCTN16561225
Clinical Trial Register
| ICTRP | ID: ictrp-ISRCTN16561225
ABSTRACT
Condition:
COVID-19 (SARS-CoV-2 infection), palliative and end of life careInfections and Infestations
Intervention:
WP1: Online survey of palliative care providers, with in-depth qualitative case study of sampled providers. Data will be collected using REDCap.
WP2: Cohort study of people with COVID-19 receiving palliative care input, with data collected at four timepoints, at first assessment (baseline, T0), 24-hour follow-up, ideally twice, but this will depend on survival (T1, T2), and then at death or discharge (D or Di).
WP1 and WP2 are run quickly, (phase I) and analysed. Then both WP1 and WP2 are repeated 6-8 weeks later (phase II), when case studies are added, to gauge key changes.
Primary outcome:
WP1. Innovations in services, workforce and volunteer deployment, and their impacts on care and bereavement services; identification of good practice, and sharing of approaches and knowledge. Change in practice, most effective treatments collected at baseline and 6-8 weeks later
WP2. Symptom and problem assessment measured using IPOS score at first assessment (baseline, T0), 24-hour follow-up, ideally twice, but this will depend on survival (T1, T2), and then at death or discharge (D or Di)
Criteria:
Inclusion criteria:WP1: Clinical leads of palliative and hospice care services including: palliative care teams in acute hospitals, in-patient hospices/palliative care wards and palliative care community services providing care in peoples own homes and supporting care homes, usually for adults and children.
WP2: Consecutive patients supported by the participating palliative care services in WP1 (including remote consultation), with clinically diagnosed and/or test confirmed COVID-19 diagnosis. This will include patients with and without pre-existing progressive conditions.
Exclusion criteria:
WP1: No lead or delegate available
WP2: Patients who are <18 years old
16.
ClinicalTrials.gov; 19/06/2020; TrialID: NCT04443179
Clinical Trial Register
| ICTRP | ID: ictrp-NCT04443179
ABSTRACT
Condition:
Autism Spectrum Disorder;Attention Deficit Hyperactivity Disorder;Neurodevelopmental Conditions;COVID-19Primary outcome:
Neurodevelopmental OutcomesCriteria:
Inclusion Criteria:
- Pregnant mothers with and without confirmed COVID-19
- Infants with and without an immediate family history of Autism Spectrum and
neurodevelopmental conditions
- Based in England, UK
Exclusion Criteria:
- based on further screening
17.
ClinicalTrials.gov; 27/05/2020; TrialID: NCT04407585
Clinical Trial Register
| ICTRP | ID: ictrp-NCT04407585
ABSTRACT
Condition:
Covid-19Intervention:
Diagnostic Test: Covid-19 swab PCR testPrimary outcome:
SARS-CoV-2 infection;SARS-CoV-2 infectionCriteria:
Study Inclusion Criteria - app users will be eligible to join the study if they:
- Are based in the UK (are using the UK version of the Covid-19 Symptom Study app, and
have listed a UK postcode)
- Are the primary app user (are reporting directly for themselves)
- Are at least 18 years of age
- Have not tested positive for a Covid-19 test before (but may have been tested)
Study Exclusion Criteria - participants are ineligible for the study if they:
- Do not meet inclusion criteria
- Do not provide informed consent to participate
Participants will be subject to further screening to identify them as eligible for swab
testing during the course of the study.
Swab inclusion criteria - participants will be eligible for swab testing if they:
- Have reported in the app at least once in the previous 3 days (days -2 to 0), and at
least two times in the previous 9 days (days -8 to 0). All reports must be healthy
(i.e. not experiencing any symptoms).
- On the previous day (day 1), have reported that they are experiencing at least one
symptom described in the app. Symptoms in the app are updated when deemed appropriate
by study investigators using evidence based reports in the scientific and medical
field.
- Have answered the phenotype fields required for the prediction model with
physiologically plausible values.
Swab exclusion criteria - participants are ineligible for swab testing if they:
- Are asymptomatic
- Do not satisfy the inclusion criteria for testing.
Insufficient testing capacity:
If insufficient testing capacity is available for the study population as described, then
recruitment will be prioritised according to:
- Firstly, most recent final healthy report before reporting symptoms
- Secondly, highest number of healthy reports during the previous 9 days before
reporting symptoms
- Thirdly, randomised selection to stratify between participants of equal priority
according to the first two rules above.
Excess testing capacity:
If excess testing capacity is available beyond the study population as described, then
inclusion criteria will be expanded in order to adequately sample across under-represented
population groups.
Specifically, on day 7 of each validation phase, investigators will assess:
- What excess testing capacity is available, if any
- Which subgroups are under-represented compared to their proportion in the UK
population (as best as can be established given that some participants may not have
completed some phenotype fields):
(i) Age decade (ii) Sex (iii) Ethnicity (iv) BMI category
For underrepresented groups, investigators may additionally recruit participants with only
one report during the previous 3 days (days -2 to 0) and no other report during the
previous 9 days (days -8 to 0).
18.
ClinicalTrials.gov; 26/05/2020; TrialID: NCT04408157
Clinical Trial Register
| ICTRP | ID: ictrp-NCT04408157
ABSTRACT
Condition:
COVIDIntervention:
Behavioral: Self-management booklet (SWitCh: Stay well during COVID-19)Primary outcome:
Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS): Tennant et al., 2007Criteria:
Inclusion Criteria:
- Aged 18 and over who live in the UK and can read and write in English, without any
current serious mental health problems (e.g. bipolar disorder, PTSD, active thoughts
of self-harm, or severe anxiety/depression) and who feel that their physical and/or
mental wellbeing have been affected since the COVID-19 pandemic.
Exclusion Criteria:
- Any current serious mental health problems (e.g. bipolar disorder, PTSD, active
thoughts of self-harm, or severe anxiety/depression) or who feel that their physical
and/or mental wellbeing have not been affected by COVID-19
19.
ClinicalTrials.gov; 23/04/2020; TrialID: NCT04363489
Clinical Trial Register
| ICTRP | ID: ictrp-NCT04363489
ABSTRACT
Condition:
Covid19Intervention:
Device: Wearable Medical Device (Empatica E4);Diagnostic Test: COVID-19 PCR Swab;Diagnostic Test: Pulse OximeterPrimary outcome:
COVID-19 InfectionCriteria:
Inclusion Criteria
- Healthy healthcare professionals of any age
Exclusion Criteria
- Previous PCR/Antibody positive test for COVID-19
- Not working in high-risk COVID-19 area (ICU, A&E, COVID positive wards)
- Involved in COVID-19 Vaccine Trial
20.
ClinicalTrials.gov; 02/04/2020; TrialID: NCT04334629
Clinical Trial Register
| ICTRP | ID: ictrp-NCT04334629
ABSTRACT
Condition:
Coronavirus;Respiratory Distress Syndrome;SARS-CoV InfectionIntervention:
Drug: IbuprofenPrimary outcome:
Disease progression;Time to mechanical ventilationCriteria:
Inclusion Criteria:
1. Male or female patients aged 18 years and above;
2. Hospitalised;
3. Confirmed or suspected SARS-CoV-2 infection;
4. National Early Warning Score (NEWS2) greater than or equal to 3 in a single parameter
or NEWS2 > 5 overall;
5. Acute hypoxemic respiratory failure: PaO2/FiO2 ratio less than or equal to 300 OR
SpO2/FiO2 ratio < 315 (Kigali Modification)
6. Provision of written informed consent by the patient OR by the patient's Legal
Representative OR professional consultee.
Exclusion Criteria:
1. Any of the following contraindications to ibuprofen:
- A known hypersensitivity to ibuprofen or any other constituent of the medicinal
product;
- Patients who have previously shown hypersensitivity reactions (e.g. asthma,
rhinitis, angioedema or urticaria) in response to aspirin or other non-steroidal
anti-inflammatory drugs (NSAIDs);
- Patients with a history of, or existing gastrointestinal ulceration/perforation
or bleeding, including that associated with NSAIDs;
- Patients with severe hepatic failure;
- Patients with acute renal failure;
- Patients with severe heart failure.
2. Participation in any other investigational drug products less than 30 days prior to
study enrolment;
3. Glasgow Coma Score < 12;
4. Patients who cannot swallow oral capsules;
5. Pregnant or lactating women;
6. Any medical history that might, in the opinion of the attending clinician, put the
patient at significant risk if he/she were to participate in the trial.