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Table 2 Domains and methods for process evaluation

From: Effectiveness of peer support to increase uptake of retinal examination for diabetic retinopathy: study protocol for the DURE pragmatic cluster randomized clinical trial in Kirinyaga, Kenya

Source

Domain

Data collection method

Stage of the trial

Trial registers

Recruitment Retention

Registers in the trial office

Throughout the trial (n = 700)

Participants

Fidelity

Reach

Dose received

Effectiveness

Participant Questionnaire

2 Focus group discussions at 6 months

At recruitment (n = 700)

Three months: n = 10% pf participants in each intervention cluster(35)

Six months: n = 10-% of participants in each cluster (35)

N = 28

Non-participant observations by PI

Recruitment

Fidelity

Dose delivered

Context

PI Field notes

N = 2 group meetings per intervention cluster during the trial (14)

Peer supporters (PS)

Effectiveness

Reach

Fidelity

Dose delivered

Context

PS Questionnaires

PS Diary for telephone calls

PS Group session report form

Focus group discussion at 6 months

After training (n = 14)

Through the trial (n = 14)

Throughout the study (1 report form per group meeting per PS)

N = 7

Eye care workers

Key informants

Context

In-depth interviews

At 6 months

N = 3

N = 7

Research project manager

Reach

Fidelity

Dose delivered

Reports

At recruitment of PS

At training the PS

At 3 and 6 months

Research nurse

Outcome evaluation procedures

Report

At 3 months and 6 months

Study steering committee

Context

Spreadsheet of external events that may have affected study outcomes

At 6 months

  1. PI Principal Investigator, PS Peer supporter