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Table 2 Process evaluation components

From: Changing illness perceptions in patients with poorly controlled type 2 diabetes, a randomised controlled trial of a family-based intervention: protocol and pilot study

Process Evaluation Questions Data Collection Tool Source Trial Stage
Implementation
Was the intervention properly delivered?
Treatment fidelity to different components.
Monitor dose/participant exposure to intervention components
1.10% of sessions randomly selected to be taped and analysed by independent expert in illness perceptions and motivational interviewing.
Tapes analysed qualitatively and quantitatively using MI & IP checklists.
Randomly selected sub-sample of intervention participant's. Collecting during intervention delivery.
Analysed post-intervention
Receipt
1.Participants views of the intervention and partaking in the RCT.
1.Open-ended questionnaires for all participants in control and intervention groups 1. All participants 1. Collected at follow-up data collection
2.Appropriateness of use of intervention and techniques for type 2 diabetes 2. Focus groups with sub-sample of intervention participants 2. Sub-sample of intervention participant's. 2. Collection post-follow-up
Contextual factors
What was the effect of various setting/contextual factors. e.g. interruptions during session, family dynamic, mood, etc.
Structured field notes questionnaire (e.g. how long each session, where in home delivered, interruptions, dynamic, etc) Interventionist Collecting during intervention delivery.
Analysed post-intervention
Sub-groups variations (e.g. family member involved) Interventionist observations – field diary