An intervention to promote self-management, independence and self-efficacy in people with early-stage dementia: the Journeying through Dementia RCT.

BACKGROUND: There are few effective interventions for dementia. AIM: To determine the clinical effectiveness and cost-effectiveness of an intervention to promote self-management, independence and self-efficacy in people with early-stage dementia. OBJECTIVES: To undertake a randomised controlled trial of the Journeying through Dementia intervention compared with usual care, conduct an internal pilot testing feasibility, assess intervention delivery fidelity and undertake a qualitative exploration of participants' experiences. DESIGN: A pragmatic two-arm individually randomised trial analysed by intention to treat. PARTICIPANTS: A total of 480 people diagnosed with mild dementia, with capacity to make informed decisions, living in the community and not participating in other studies, and 350 supporters whom they identified, from 13 locations in England, took part. INTERVENTION: Those randomised to the Journeying through Dementia intervention (n = 241) were invited to take part in 12 weekly facilitated groups and four one-to-one sessions delivered in the community by secondary care staff, in addition to their usual care. The control group (n = 239) received usual care. Usual care included drug treatment, needs assessment and referral to appropriate services. Usual care at each site was recorded. MAIN OUTCOME MEASURES: The primary outcome was Dementia-Related Quality of Life score at 8 months post randomisation, with higher scores representing higher quality of life. Secondary outcomes included resource use, psychological well-being, self-management, instrumental activities of daily living and health-related quality of life. RANDOMISATION AND BLINDING: Participants were randomised in a 1 : 1 ratio. Staff conducting outcome assessments were blinded. DATA SOURCES: Outcome measures were administered in participants' homes at baseline and at 8 and 12 months post randomisation. Interviews were conducted with participants, participating carers and interventionalists. RESULTS: The mean Dementia-Related Quality of Life score at 8 months was 93.3 (standard deviation 13.0) in the intervention arm (n = 191) and 91.9 (standard deviation 14.6) in the control arm (n = 197), with a difference in means of 0.9 (95% confidence interval -1.2 to 3.0; p = 0.380) after adjustment for covariates. This effect size (0.9) was less than the 4 points defined as clinically meaningful. For other outcomes, a difference was found only for Diener's Flourishing Scale (adjusted mean difference 1.2, 95% confidence interval 0.1 to 2.3), in favour of the intervention (i.e. in a positive direction). The Journeying through Dementia intervention cost £608 more than usual care (95% confidence interval £105 to £1179) and had negligible difference in quality-adjusted life-years (-0.003, 95% confidence interval -0.044 to 0.038). Therefore, the Journeying through Dementia intervention had a mean incremental cost per quality-adjusted life-year of -£202,857 (95% confidence interval -£534,733 to £483,739); however, there is considerable uncertainty around this. Assessed fidelity was good. Interviewed participants described receiving some benefit and a minority benefited greatly. However, negative aspects were also raised by a minority. Seventeen per cent of participants in the intervention arm and 15% of participants in the control arm experienced at least one serious adverse event. None of the serious adverse events were classified as related to the intervention. LIMITATIONS: Study limitations include recruitment of an active population, delivery challenges and limitations of existing outcome measures. CONCLUSIONS: The Journeying through Dementia programme is not clinically effective, is unlikely to be cost-effective and cannot be recommended in its existing format. FUTURE WORK: Research should focus on the creation of new outcome measures to assess well-being in dementia and on using elements of the intervention, such as enabling enactment in the community. TRIAL REGISTRATION: This trial is registered as ISRCTN17993825. FUNDING: This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 26, No. 24. See the NIHR Journals Library website for further project information.

There are few services proven effective for people with mild dementia. We therefore explored the potential benefit of a programme called Journeying through Dementia. The content, devised in partnership with people living with dementia, aims to help affected individuals to live well and participate in life. The programme involves meeting in groups of about eight every week for 12 weeks. Each person also has four face-to-face meetings with a staff member. Carers are invited to 3 of the 12 group meetings to all individual meetings if the participant wanted this involvement. A total of 480 people with dementia and 350 carers from 13 locations in England took part. Just over half of the participants were randomly allocated to the new programme, whereas the others were not. This allowed us to compare the groups. We were interested in whether or not attending the Journeying through Dementia programme improved participants' quality of life. The results showed that it did not. We also measured participants' mood, self-management skills, positive attitudes and ability with daily living skills. Only one measure of positive psychology suggested even a small benefit. There was no difference between groups in the remaining measures. Although some individual participants described being more confident, enjoying social contact, trying new activities, feeling valued and having increased independence, overall, the programme is unlikely to be worth implementing. Certain aspects of the programme are worth implementing.

Journeying through Dementia, a community-based self-management intervention for people aged 65 years and over: a feasibility study to inform a future trial.

BACKGROUND: A study to determine the feasibility of conducting a future population-based trial into a self-management intervention for community-living adults with early stage dementia included evaluation of intervention content and modes of delivery, staffing requirements, recruitment methods and the utility and usability of patient reported outcomes. METHODS: Participants identified through memory clinics in one city took part in an intervention called 'Journeying through Dementia'. The 12-week programme incorporating four individual sessions with one of the facilitators encourages participants to engage in discussion and activities related to health and well-being positioning them as the expert enabling long-term behavioural change. Participants (n = 10) and their nominated carers (n = 7) were all asked to complete selected outcomes at baseline, 8 weeks (participants only) and post intervention and invited to comment on their usability. All participants and carers were qualitatively interviewed before intervention delivery about their expectations and participants; nominated carers and facilitators were all interviewed after cessation about their experiences. RESULTS: The manualised intervention and modes of delivery proved acceptable to participants and carers. Reported benefits included increased confidence and self-efficacy, engagement in new or lapsed activities and re-engagement in fun and friendships. People with dementia and carers were able to self-complete all outcome measures, but time required to complete the measures is a key factor. Strategies for recruitment need to include direct contact within 24-48 h post invitation to the study. Analysis of data on the primary outcome did not reveal any trends. Facilitators found the training and support to be appropriate and helpful. CONCLUSIONS: The tailored intervention reportedly met the needs of all participants. The study confirmed the need for careful identification and application of patient-reported outcome measures. Outcomes to measure some dimensions of reported benefit are not available. TRIAL REGISTRATION: Current Controlled Trials ISRCTN67209155.

Plasma angiotensin-converting enzyme in Alzheimer's disease.

The insertion allele in the gene encoding angiotensin-converting enzyme (ACE) is a risk factor for Alzheimer's disease (AD) and ACE is one of several peptidases that have the ability to degrade the neurotoxic amyloid-beta peptide. ACE is a membrane-bound peptidase that is also present in a soluble form in plasma as a result of a zinc metalloprotease-mediated shedding event. Here we aimed to determine whether there is a difference in ACE in the plasma of late-onset clinically diagnosed AD patients (n = 94) as compared to age-matched non-demented control subjects (n = 188). Plasma ACE was lower in the AD subjects as compared to the controls both at baseline (p = 0.072) and after two years (p = 0.05). There was a greater reduction in plasma ACE in the AD subjects as compared to the control subjects over the two years. Plasma ACE did not correlate with cognitive function. The observed reduction in plasma ACE in AD may reflect a general decrease in the zinc metalloprotease-mediated shedding of a subset of membrane-bound proteins.

Carer burden in dementia--assessing the impact of behavioural and psychological symptoms via self-report questionnaire.

BACKGROUND: The relationship between the behavioural and psychological symptoms of dementia (BPSD) and negative outcomes in carers has been consistently demonstrated, however the quality of the assessment of the former in routine clinical settings is variable and validated interview-based scales are frequently underutilised. AIMS: To develop a carer self-report questionnaire, the Behavioural and Psychological Symptoms Questionnaire (BPSQ), for the assessment of the neuropsychiatric symptoms of dementia and associated carer distress. METHOD: The BPSQ was administered to the carers of 30 community-dwelling older adults with diagnoses of Alzheimer's or vascular dementia and the results compared with interview assessment using the Neuropsychiatric Inventory (NPI). RESULTS: BPSD were present in 96.2% of patients. There was strong correlation (r(s) = 0.61, p < 0.001) between the BPSQ and interview with respect to measures of symptom frequency and severity. However, there was significant divergence between the two assessment schedules with respect to carer distress which was found to be significantly under-reported in the initial interview (U = 64.00, z = -5.22, p < 0.0001). CONCLUSIONS: The BPSQ is an effective tool to complement clinical interview in the assessment and monitoring of BPSD, and provides useful additional information with respect to carer distress, which currently may be under recognised. A follow-up study is required to complete the work of validating the BPSQ.

Increased circulating insulin-like growth factor-1 in late-onset Alzheimer's disease.

BACKGROUND: Insulin-like growth factor (IGF)-1 has been implicated in the pathogenesis of Alzheimer's disease (AD). METHODS: We compared the level of circulating total and bioavailable IGF-1, by simultaneous measurements of IGF-1 and IGF binding protein (IGFBP)-3, between 87 patients diagnosed with AD and 126 age and sex matched control subjects without cognitive impairment. Blood samples were collected and IGF-1 and IGFBP-3 measured by ELISA. Subjects were also genotyped for apolipoprotein E. RESULTS: Total circulating IGF-1 levels were significantly raised in the AD group as compared to the control group (p=0.022). There was no significant difference in the circulating level of IGFBP-3 between the two groups. When the IGF-1 levels were ratioed against IGFBP-3 levels as an indicator of unbound, bioavailable circulating IGF-1, there was a significant increase in the molar IGF-1:IGFBP-3 ratio in the AD subjects (0.181 +/- 0.006) as compared to the controls (0.156 +/- 0.004) (p< 0.001). Logistic regression analysis revealed that an increase in the IGF-1:IGFBP-3 molar ratio increased the risk of AD significantly. CONCLUSION: The results of increased total and free circulating IGF-1 support the hypothesis that in its early stages late-onset AD reflects a state of resistance to IGF-1.

Clinical medication review by a pharmacist of elderly people living in care homes--randomised controlled trial.

OBJECTIVE: to measure the impact of pharmacist-conducted clinical medication review with elderly care home residents. DESIGN: randomised controlled trial of clinical medication review by a pharmacist against usual care. SETTING: sixty-five care homes for the elderly in Leeds, UK. PARTICIPANTS: a total of 661 residents aged 65+ years on one or more medicines. INTERVENTION: clinical medication review by a pharmacist with patient and clinical records. Recommendations to general practitioner for approval and implementation. Control patients received usual general practitioner care. MAIN OUTCOME MEASURES: primary: number of changes in medication per participant. Secondary: number and cost of repeat medicines per participant; medication review rate; mortality, falls, hospital admissions, general practitioner consultations, Barthel index, Standardised Mini-Mental State Examination (SMMSE). RESULTS: the pharmacist reviewed 315/331 (95.2%) patients in 6 months. A total of 62/330 (18.8%) control patients were reviewed by their general practitioner. The mean number of drug changes per patient were 3.1 for intervention and 2.4 for control group (P < 0.0001). There were respectively 0.8 and 1.3 falls per patient (P < 0.0001). There was no significant difference for GP consultations per patient (means 2.9 and 2.8 in 6 months, P = 0.5), hospitalisations (means 0.2 and 0.3, P = 0.11), deaths (51/331 and 48/330, P = 0.81), Barthel score (9.8 and 9.3, P = 0.06), SMMSE score (13.9 and 13.8, P = 0.62), number and cost of drugs per patient (6.7 and 6.9, P = 0.5) (pounds sterling 42.24 and pounds sterling 42.94 per 28 days). A total of 75.6% (565/747) of pharmacist recommendations were accepted by the general practitioner; and 76.6% (433/565) of accepted recommendations were implemented. CONCLUSIONS: general practitioners do not review most care home patients' medication. A clinical pharmacist can review them and make recommendations that are usually accepted. This leads to substantial change in patients' medication regimens without change in drug costs. There is a reduction in the number of falls. There is no significant change in consultations, hospitalisation, mortality, SMMSE or Barthel scores.

Are people with mild cognitive impairment aware of the benefits of errorless learning?

Mild cognitive impairment (MCI) has been described as a memory deficit in the absence of other cognitive dysfunction. It can be thought of as a pre-clinical dementia. Memory impairment in this group is not as severe as in early dementia and thus learning is still possible. We were interested to see if errorless learning, a widely used rehabilitation technique, was of benefit to people with MCI. Since it has been shown that successful rehabilitation is somewhat contingent on awareness of function, we were also interested to see if people with MCI were aware of the benefits of errorless learning. The present study employed an errorless learning procedure on 16 people with MCI and 16 older adult controls to learn two lists of 10 words in errorless and errorful learning conditions. We adopted a metacognitive approach measuring people's memory monitoring through judgements of learning (JOLs) a prediction of future memory performance. The results revealed errorless learning is an effective memory rehabilitation tool for people with MCI, with significant increases in recall performance for both groups relative to errorful learning. Most interestingly participants were aware of the benefits of errorless learning in their JOLs. MCI participants and controls both had significantly higher JOLs for words studied under errorless learning conditions. The learning performance in MCI and theories of metacognitive awareness are discussed.