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Though prior trials have shown the effectiveness of community-based hypertension detection and care delivery models, their adoption and translation to practice has been slow. In this study, we will develop and test strategies for the implementation and scale-up of a proven multicomponent hypertension intervention (MCHI) in Pakistan that comprises health education, blood pressure (BP) monitoring and referrals by lady health workers (LHWs) and hypertension management by physicians in primary care settings.
In this 24-month hybrid type III implementation-effectiveness cluster-randomised controlled trial, we will recruit 3000 adult hypertensive patients from two rural districts of Pakistan. We will engage public health sector managers, physicians and LHWs and use the Consolidated Framework for Implementation Research to identify barriers and facilitators to the implementation of an already proven-to-be-effective MCHI. Using Expert Recommendations for Implementing Change and the modified Delphi technique, a set of implementation strategies addressing barriers will be identified. The strategies will be categorised as level 1 (requiring a change in processes), level 2 (requiring a change in infrastructure) and level 3 (financial restructuring). Basic health units and 250–300 households from their catchment will be considered as clusters. Clusters will be randomised in a ratio of 1:1 to intervention and control. While MCHI will be offered in both trial arms (intervention and control), the aforementioned implementation strategies will be randomised to the intervention arm only, starting with level 1 and moving to levels 2 and 3 as needed. Baseline and 6-monthly follow-up surveys, each of 6 months duration, will be conducted to collect data from the recruited participants on sociodemographics, cardiovascular disease (CVD) risk factors, CVD-related expenses and quality of life. The primary outcome will be the mean difference in BP-lowering medications per participant between the intervention and control arms. The primary outcome will be analysed using a linear mixed model with fixed effects for baseline value of the outcome. Additional outcomes include implementation outcomes: proportion of LHWs conducting health education, BP screening and monitoring, facility referrals and proportion of physicians diagnosing and treating hypertensive patients; effectiveness outcomes: proportion of participants with controlled BP and improved EQ-5D-5L score.
Ethical approval has been obtained from the Ethics Review Committee of Aga Khan University Pakistan (ERC # 2023-9084-26739). Findings will be reported to: (1) study participants; (2) funding body and institutes collaborating and supporting the study; (3) provincial and district health departments to inform policy; (4) presented at local, national and international conferences and (5) disseminated by peer-review publications
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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