Background and Aims

SPRINT INDIA trial delivers intervention in form of educational workbook, videos and SMS using internet, on cellular device, across 30 centres in 12 languages. Primary outcome was composite of recurrent stroke, transient ischemic attack, acute coronary syndrome and death at one year. Sample size was 5930 but only 4298 patients could be randomised as trial had to be stopped for futility. Only 5% primary outcomes were reported, rather than the expected 15-20% reported in India. Data analysis indicated that trial secondary stroke awareness intervention was no better than standard awareness.

Process evaluation was conducted to comprehend the futile outcomes by examining trial implementation and exploring participant’s perspectives.

Methods

Using mixed methods approach, qualitative interviews from 11 sampled sites representing regional languages in which intervention was delivered were conducted. Quantitative data includes case report forms, workbooks and questionnaires to measure intervention fidelity and contamination.

Results

Total 111 interviews of patients/caregivers (80) and health professionals (31) with 2 focus group interviews were conducted. Fidelity questionnaire was responded by 1418 (66%) out of 2148. SMS and videos at 6 weeks were viewed by 996 (70%) and 769 (54%), at 6 months 571 (40%) and 534 (38%) and at 1 year 506 (36%) and 460 (32%) respectively. Contamination questionnaire was responded by 1869 (87%) controls out of 2150 and none reported any intervention material knowledge. Average activities performed in workbook were Median (IQR): 9 (4-12) out of total 15.

Conclusions

Reasons identified for decreased viewing were repetitive content and non-availability of their own cellular device with patients.

Background and Aims

Process Evaluation (PE) is performed to investigate trial activities to verify their implementation to interpret and explain outcomes and provide input for future planning. Complex intervention has numerous characters and outcomes are produced due to external determinants and applied context. Secondary disease prevention trials are pharmacologic and behavioural including using internet and mobile technology.

Aim of review is to broadly investigate PEs performed on complex secondary disease prevention trials requiring behaviour change with emphasis on rehabilitation, stroke, internet and mobile based interventions.

Methods

Based on recommendations for scoping reviews in Systematic Reviews guidelines, literature review was undertaken on electronic databases – PubMed, Web of science and Cochrane library from year 2012 to 2021. Following data were extracted: type of prevention trial, multi /single centre, PE tools, analysis method and drawbacks.

Results

There were 17 trials identified where PE was performed according to given key words. These were divided into 5 categories according to type of trial –

General rehabilitation & prevention

Rehabilitation & prevention- internet delivered

Mobile health led non-stroke disease prevention

Stroke rehabilitation

Mobile phone based stroke rehabilitation.

Most trials were multicentre (n=12) which conducted evaluation with mixed methods (MMs) approach (n=13). Thematic analysis was performed in 5 and realist in 5. Major drawbacks of evaluations were lack of detailed analysis (n=10), positive bias (n=3), quantitative data not evaluated (n=2) and finite pilot study (n=2).

Conclusions

Findings suggest that PE is purposeful when performed using MMs and analysed with robust theoretical frameworks with triangulation of qualitative and quantitative data with trial results.