Abstract
BackgroundIntervention fidelity is the core component of a well-designed clinical trial and processes that are used to ensure that the study intervention is delivered as planned. It affects the design and implementation of a study as well as the analysis of the results and interpretation of the findings. The objectives of this study are (a) to describe the methods of assessing the intervention fidelity used in the peer-led chronic pain management program (PAP) and (b) to report the findings on the PAP’s intervention fidelity.MethodsTo optimize fidelity to the intervention, we used various strategies and measured them in a continuous process using several different approaches: (a) peer volunteer (PV) training workshop, (b) biweekly meetings with the research team, (c) a detailed teaching manual, (d) a fidelity checklist, (e) on-site visits and direct observations, and (f) semi-structured interview.ResultsThe PVs’ attendance was high, and most of them achieved a high level of implementation in following the fidelity checklist. As part of a large clustered RCT, the fidelity assessment was carried out to help determine the effectiveness of the intervention.ConclusionsOverall, the PVs successfully delivered the intervention, and the results of the study indicate the effectiveness of the PAP.Trial registrationClinicalTrials.govNCT03823495. Registered on 30 January 2019.
Highlights
Intervention fidelity is the core component of a well-designed clinical trial and processes that are used to ensure that the study intervention is delivered as planned
The intervention that we designed for our study was a peer-led chronic pain management program (PAP) led by a peer volunteer (PV) using a teaching manual, and the group that received this intervention was compared with a group that received the usual care
Volunteers were recruited and trained to lead the PAP for older adults. These volunteers were recruited from an institute hosted by a local university in HK based on the following criteria: (1) Older than 55 years old (2) Scored over 6 in the Abbreviated Mental Test (AMT) (3) Be willing to lead the PAP in a nursing home
Summary
Intervention fidelity is the core component of a well-designed clinical trial and processes that are used to ensure that the study intervention is delivered as planned. It affects the design and implementation of a study as well as the analysis of the results and interpretation of the findings. The objectives of this study are (a) to describe the methods of assessing the intervention fidelity used in the peer-led chronic pain management program (PAP) and (b) to report the findings on the PAP’s intervention fidelity. The study that we conducted was a clustered randomized control trial entitled Effectiveness of a peer-led pain management program in relieving chronic pain and enhancing pain self-efficacy among older adults. The focus of our study was on the ability to manage pain and pain-related symptoms, the treatment of pain, and the physical and psychosocial consequences and lifestyle changes inherent in living with a chronic pain condition
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