Intervention development of 'Diabetes Together' using the person-based approach: a couples-focused intervention to support self-management of type 2 diabetes in South Africa.

OBJECTIVES: Type 2 diabetes (T2D) is a growing concern in South Africa, where many find self-management challenging. Behaviour-change health interventions are enhanced by involving partners of patients. We aimed to develop a couples-focused intervention to improve self-management of T2D among adults in South Africa. DESIGN: We used the person-based approach (PBA): synthesising evidence from existing interventions; background research; theory; and primary qualitative interviews with 10 couples to ascertain barriers and facilitators to self-management. This evidence was used to formulate guiding principles that directed the intervention design. We then prototyped the intervention workshop material, shared it with our public and patient involvement group and ran iterative co-discovery think-aloud sessions with nine couples. Feedback was rapidly analysed and changes formulated to improve the intervention, optimising its acceptability and maximising its potential efficacy. SETTING: We recruited couples using public-sector health services in the area of Cape Town, South Africa, during 2020-2021. PARTICIPANTS: The 38 participants were couples where one person had T2D. INTERVENTION: We developed the 'Diabetes Together' intervention to support self-management of T2D among couples in South Africa, focussing on: improved communication and shared appraisal of T2D; identifying opportunities for better self-management; and support from partners. Diabetes Together combined eight informational and two skills-building sections over two workshops. RESULTS: Our guiding principles included: providing equal information on T2D to partners; improving couples' communication; shared goal-setting; discussion of diabetes fears; discussing couples' roles in diabetes self-management; and supporting couples' autonomy to identify and prioritise diabetes self-management strategies.Participants viewing Diabetes Together valued the couples-focus of the intervention, especially communication. Feedback resulted in several improvements throughout the intervention, for example, addressing health concerns and tailoring to the setting. CONCLUSIONS: Using the PBA, our intervention was developed and tailored to our target audience. Our next step is to pilot the workshops' feasibility and acceptability.

A randomised controlled trial of a digital intervention (Renewed) to support symptom management, wellbeing and quality of life in cancer survivors.

BACKGROUND: Many cancer survivors following primary treatment have prolonged poor quality of life. AIM: To determine the effectiveness of a bespoke digital intervention to support cancer survivors. DESIGN: Pragmatic parallel open randomised trial. SETTING: UK general practices. METHODS: People having finished primary treatment (<= 10 years previously) for colo-rectal, breast or prostate cancers, with European-Organization-for-Research-and-Treatment-of-Cancer QLQ-C30 score <85, were randomised by online software to: 1)detailed 'generic' digital NHS support ('LiveWell';n=906), 2) a bespoke complex digital intervention ('Renewed';n=903) addressing symptom management, physical activity, diet, weight loss, distress, or 3) 'Renewed-with-support' (n=903): 'Renewed' with additional brief email and telephone support. RESULTS: Mixed linear regression provided estimates of the differences between each intervention group and generic advice: at 6 months (primary time point: n's respectively 806;749;705) all groups improved, with no significant between-group differences for EORTC QLQ-C30, but global health improved more in both intervention groups. By 12 months there were: small improvements in EORTC QLQ-C30 for Renewed-with-support (versus generic advice: 1.42, 95% CIs 0.33-2.51); both groups improved global health (12 months: renewed: 3.06, 1.39-4.74; renewed-with-support: 2.78, 1.08-4.48), dyspnoea, constipation, and enablement, and lower NHS costs (generic advice £265: in comparison respectively £141 (153-128) and £77 (90-65) lower); and for Renewed-with-support improvement in several other symptom subscales. No harms were identified. CONCLUSION: Cancer survivors quality of life improved with detailed generic online support. Robustly developed bespoke digital support provides limited additional short term benefit, but additional longer term improvement in global health enablement and symptom management, with substantially lower NHS costs.

The Active Brains Digital Intervention to Reduce Cognitive Decline in Older Adults: Protocol for a Feasibility Randomized Controlled Trial.

BACKGROUND: Increasing physical activity, improving diet, and performing brain training exercises are associated with reduced cognitive decline in older adults. OBJECTIVE: In this paper, we describe a feasibility trial of the Active Brains intervention, a web-based digital intervention developed to support older adults to make these 3 healthy behavior changes associated with improved cognitive health. The Active Brains trial is a randomized feasibility trial that will test how accessible, acceptable, and feasible the Active Brains intervention is and the effectiveness of the study procedures that we intend to use in the larger, main trial. METHODS: In the randomized controlled trial (RCT), we use a parallel design. We will be conducting the intervention with 2 populations recruited through GP practices (family practices) in England from 2018 to 2019: older adults with signs of cognitive decline and older adults without any cognitive decline. Trial participants were randomly allocated to 1 of 3 study groups: usual care, the Active Brains intervention, or the Active Brains website plus brief support from a trained coach (over the phone or by email). The main outcomes are performance on cognitive tasks, quality of life (using EuroQol-5D 5 level), Instrumental Activities of Daily Living, and diagnoses of dementia. Secondary outcomes (including depression, enablement, and health care costs) and process measures (including qualitative interviews with participants and supporters) will also be collected. The trial has been approved by the National Health Service Research Ethics Committee (reference 17/SC/0463). RESULTS: Results will be published in peer-reviewed journals, presented at conferences, and shared at public engagement events. Data collection was completed in May 2020, and the results will be reported in 2021. CONCLUSIONS: The findings of this study will help us to identify and make important changes to the website, the support received, or the study procedures before we progress to our main randomized phase III trial. TRIAL REGISTRATION: International Standard Randomized Controlled Trial Number 23758980; http://www.isrctn.com/ISRCTN23758980. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/18929.