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Participation in physical activity (PA) is a cornerstone of the secondary prevention of stroke. Given the heterogeneous nature of stroke, PA interventions that are adaptive to individual performance capability and associated co-morbidity levels are recommended. Mobile health (mHealth) has been identified as a potential approach to supporting PA post-stroke. To this end, we used a Sequential Multiple Assignment Randomised Trial design to develop an adaptive, mHealth intervention to improve PA post-stroke – The Adaptive Physical Activity programme in Stroke (TAPAS) (Clinicaltrials.Gov NCT05606770). As the first trial in stroke recovery literature to use this design, there is an opportunity to conduct a process evaluation for this type of adaptive intervention. The aim of this process evaluation is to examine the implementation process, mechanism of change and contextual influences of TAPAS among ambulatory people with stroke in the community.
Guided by the Medical Research Council Framework for process evaluations, qualitative and quantitative methods will be used to examine the (1) implementation process and the content of TAPAS (fidelity adaptation, dose and reach); (2) mechanisms of change (participants’ response to the intervention; mediators; unexpected pathways and consequences) and (3) influence of the context of the intervention. Quantitative data will be presented descriptively, for example, adherence to exercise sessions. Qualitative data will be collected among TAPAS participants and the interventionist using semi-structured one-to-one or focus group interviews. Transcribed interviews will be analysed using reflexive thematic analysis. Key themes and sub-themes will be developed.
Ethical approval has been granted by the Health Service Executive Mid-Western Ethics Committee (REC Ref: 026/2022) (25/03/2024). The findings will be submitted for publication and presented at relevant national and international academic conferences.
The ‘Developing and evaluating an adapted behavioural activation intervention for depression and diabetes in South Asia (DiaDeM)’ trial investigates a psychological intervention, behavioural activation (BA), on people with both diabetes and depression in Bangladesh and Pakistan. This study aimed to aid the intervention and trial design.
This was a modelling study using microsimulation to assess the intervention’s cost-effectiveness. Diabetes was modelled using the UK Prospective Diabetes Study model based on Pakistani patients and depression was modelled using Patient Health Questionnaire-9 (PHQ-9) trajectories allowing for multiple depressive episodes. It was assumed that diabetes-related adverse events increased depression recurrence, while depression impacted haemoglobin A1c, increasing diabetes-related events. The model estimated (1) maximum cost of BA which would be cost-effective (headroom analysis) to inform intervention design, and (2) value of reducing uncertainty around different measures (value of information analysis) to prioritise data collection in the DiaDeM study.
Analysis was conducted from a Pakistani healthcare perspective over a lifetime with costs and outcomes discounted at 3%.
BA plus usual care was compared against usual care. BA involved six sessions by a trained (non-mental health) facilitator. The usual care comparator was the prevailing mix of pharmacological and non-pharmacological treatments used in Pakistan.
The primary outcome was disability-adjusted life-years (DALYs). Secondary outcomes included life years, healthcare costs and the rate of depression and diabetes-related events.
Over their lifetime, individuals receiving BA plus usual care avoid 3.2 (95% credible interval: 2.7 to 3.8) years of mild depression and experience fewer diabetes-related events. BA plus usual care resulted in an additional 0.27 (0.03 to 0.52) life years, 0.98 (0.45 to 1.86) DALYs averted and had incremental healthcare costs of –US$97 (–US$517 to US$142), excluding BA costs. The maximum cost per BA course at which was cost-effective is US$83 (US$9 to US$214). Value of information analysis found the most important measures to include in the trial are the impact of depression on diabetes and PHQ-9 over time.
This is the first model to jointly model depression and diabetes for South Asia and uses novel methods to reflect the diseases and inform intervention and trial design. This evidence has helped to inform the design of the DiaDeM intervention and the trial to evaluate it.
DiaDeM trial: ISRCTN40885204, DOI: ; pre-results, DOI:
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