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Table 1 Details of case studies

From: Challenges in the design, planning and implementation of trials evaluating group interventions

StudyPopulation (target)Group intervention [additional sessions]Facilitator (per session)Method and timing of recruitmentType and timing of randomisationOutcome 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 cohortIndividual.
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-outCluster 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 teamIndividual.
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
  1. GP general practitioner