Table 1 Details of case studies
From: Challenges in the design, planning and implementation of trials evaluating group interventions
| Study | Population (target) | Group intervention [additional sessions] | Facilitator (per session) | Method and timing of recruitment | Type and timing of randomisation | Outcome data collection |
|---|---|---|---|---|---|---|
| LM [2] | 65+ years (prevention: general) | 16 × weekly sessions: 2-h face-to-face occupational therapy [4 × one-to-one sessions] | Two NHS Band 4 equivalent staff. Recruited on university contracts specifically to deliver the intervention Training: two- day face-to-face course | Mail-out via GPs, healthcare referral and self-referral from study promotion (including researchers visiting dementia cafes and other groups) | Individual. Done by central team immediately after consent and baseline data collection | Central research assistants; blinded outcome assessor; follow-up anchored to randomisation |
| PLINY [3] | 75+ years (prevention: loneliness) | 12 × weekly sessions: 1-h telephone friendship [6 × one-to-one telephone calls before group] | One volunteer from a community organisation. Training: 4 × 1 h sessions via telephone | Mail-out via GPs and to research cohort | Individual. Done by central team immediately after consent and baseline data collection | Central research assistants; blinded outcome assessor; follow-up anchored to randomisation |
| REPOSE [4] | 18+ years. Type I diabetes (therapy: self-care education) | 5 × daily sessions: full-day face-to-face Education (total approx. 38 h). [1 optional × group follow-up session] | Two diabetes specialist nurses/dieticians. Training: five- day observation, three-day face-to-face workshop, peer-reviewed delivery of five-day course and one-day workshop (105 h) | Referral via care team in person or via mail-out | Cluster by course in pairs. Delayed randomisation: after groups were filled, 6 weeks before first course; baseline taken after randomisation | Facilitator at clinic visits; unblinded outcome assessor; follow-up anchored to group attendance |
| STEPWISE [5] | 18+ years. First episode psychosis + schizophrenia (prevention: cardiovascular) | 4 × weekly sessions: 2.5-h face-to-face. [3 × quarterly booster group sessions and fortnightly 1:1 support calls between booster sessions] | Two NHS staff (mental health staff; occupation therapists and dieticians). Training: three-day face-to-face course plus one-day booster session training | Referral via care team | Individual. Done immediately after consent and baseline data collection | CMHT staff or research nurses; blinded outcome assessor; follow-up anchored to randomisation |
| JtD [1] | 18+ years. Dementia (prevention: dependency) | 12 × weekly sessions: Approx. 2-h face-to-face psychosocial education [4 × one-to-one sessions] | Two NHS staff. Training: two-day face-to-face course, plus online resources | Mail-out via GPs/care teams, mail-out to research cohort by research team, referral via care team, or self-referral from study promotion (including researchers visiting dementia cafes and other groups) | Individual. Delayed randomisation: after collection of baseline data < 2 months before intervention | Central and local site research assistants; blinded outcome assessor; follow-up anchored to randomisation |