Department of Neurology, Christian Medical College, Ludhiana, Punjab, India.
School of Pharmacy, Desh Bhagat University, Mandi Gobindgarh, Punjab, India.
Eur Stroke J. 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 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.
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.
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.
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.
INDIA 试验中的结构化半交互式卒中预防包进行了二级卒中意识干预，以工作簿、视频和短信的形式向 31 个中心的亚急性卒中患者提供，使用 12 种语言。由于血管结局比预期的少，试验因无效而停止。试验结果表明，试验干预并没有导致血管事件的减少。我们进行了过程评估，以评估试验的实施和参与者的观点，以理解试验的无效结果。
采用混合方法，对病例报告表、工作簿和问卷中的定性访谈和定量数据进行分析，以衡量干预的一致性和污染。使用目的抽样，在 11 个中心对 115 对患者-照顾者对和卫生专业人员进行了访谈，并进行了 2 次焦点小组讨论。
对定性数据进行了迭代主题分析，并使用了 RE-AIM 和现实主义模型。干预的一致性和对方案的遵守都很好；然而，通过随机招募未受教育和依赖照顾者的患者，纳入标准被稀释了。中心协调员按照方案为两个臂提供咨询，造成了偏见。协调员发现很难让患者有动力观看干预，这一点在一致性问卷中得到了证实，即一年来观看干预的次数减少了。由于参与试验，常规护理中的心血管保护得到了改善。没有报道干预的污染。
该干预措施得到了患者和照顾者的认可，可以作为社区为基础的项目。观看次数减少的原因是内容重复和没有个人手机设备。
