Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2023 Dec;8(4):1053-1063.
doi: 10.1177/23969873231192291. Epub 2023 Aug 10.

Secondary prevention by structured semi-interactive stroke prevention package in INDIA (SPRINT INDIA): Findings from the process evaluation of a randomized controlled trial

Shweta Jain Verma  1 , Puja Gulati  2 , Ranjit J Injety  1 , Deepti Arora  1 , Aneesh Dhasan  3 , Anusha Singhania  1 , Himani Khatter  1 , Meenakshi Sharma  4 , Padmavathyamma Narayanapillai Sylaja  3 , Jeyaraj Durai Pandian  1
Affiliations
Randomized Controlled Trial

Secondary prevention by structured semi-interactive stroke prevention package in INDIA (SPRINT INDIA): Findings from the process evaluation of a randomized controlled trial

Shweta Jain Verma et al. Eur Stroke J. 2023 Dec.

Abstract

Introduction: Secondary Prevention by Structured Semi-Interactive Stroke Prevention Package in INDIA Trial delivered secondary stroke awareness intervention to sub-acute stroke patients in form of workbook, videos and SMS across 31 centres in 12 languages. Trial was stopped for futility due to fewer vascular outcomes than anticipated. Trial results indicated that trial intervention, did not lead to reduction in vascular events. We carried out process evaluation, to evaluate trial implementation and participant's perspectives, to comprehend the trial's futile outcomes.

Materials and methods: Using mixed methods approach, qualitative interviews and quantitative data from case report forms, workbooks and questionnaires were analysed to measure intervention fidelity and contamination. Using purposive sampling, 115 interviews of patient-caregiver dyads and health professionals at 11 centres and 2 focus group discussions were held.

Results and discussion: Iterative thematic analysis of qualitative data was done with RE-AIM and realist models. There was good fidelity to intervention and adherence to protocol; however, there was dilution of inclusion criteria by randomly enrolling uneducated and caregiver-dependent patients. Centre coordinators provided counselling to both arms, not specified by protocol, causing bias. Coordinators found it difficult to keep patients motivated to view intervention which was corroborated by fidelity questionnaire showing decreased viewing of intervention for a year. Cardiovascular protection improved in routine care by virtue of participating in trial. No contamination of intervention was reported.

Conclusion: The intervention was acceptable by patients and caregivers, which could be made a community-based programme. Reasons identified for decreased viewing were repetitive content and non-availability of personal cellular device.

Keywords: Secondary stroke prevention; interviews; mixed methods; process evaluation; thematic analysis.

PubMed Disclaimer

Conflict of interest statement

Declaration of conflicting interestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Figures

Figure 1.
Figure 1.
SPRINT INDIA process evaluation framework.
Figure 2.
Figure 2.
SPRINT INDIA process evaluation findings summary.
Figure 3.
Figure 3.
Quantitative results of SPRINT INDIA process evaluation.
See this image and copyright information in PMC

References

    1. GBD 2019 Stroke Collaborators. Global, regional, and national burden of stroke and its risk factors, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet Neurol 2021; 20: 795–820. - PMC - PubMed
    1. Jones SP, Baqai K, Clegg A, et al. Stroke in India: a systematic review of the incidence, prevalence, and case fatality. Int J Stroke 2022; 17: 132–140. - PMC - PubMed
    1. Kamalakannan S, Gudlavalleti AV, Gudlavalleti VM, et al. Incidence & prevalence of stroke in India: a systematic review. Ind J Med Res 2017; 146: 175–185. - PMC - PubMed
    1. Das SK, Banerjee TK, Biswas A, et al. A prospective community-based study of stroke in Kolkata, India. Stroke 2007; 38: 906–910. - PubMed
    1. Verma SJ, Narang GS, William A, et al. An observational study of recurrent stroke in northwest India. Int J Stroke 2016; 1: 258.

Publication types