Charlesworth 2016.
Methods | Factorial pragmatic RCT. | |
Participants | 291 community‐dwelling people in the UK, with a diagnosis of dementia according to DSM‐IV and their family carers. 144 participants were in groups relevant to the current review. Mean age: 74.21 years. |
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Interventions | Intervention 1: group reminiscence (RYCT) for people with dementia and their carers (RYCT program) Control: treatment as usual Intervention 2: carer support programme. Intervention 3: both intervention 1 and intervention 2 The current review used data from participants in the RYCT (only) and treatment as usual (only) groups. |
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Outcomes | Quality of life: QoL‐AD, EQ‐5D, DEMQOL. Behavioural: ADCS‐ADL. Mood‐related outcomes: HADS, NPI, QCPR. Carer: mental component score of the UK Short Form‐12 Health Survey (UK SF‐12), EQ‐5D, HADS, Emotional Loneliness Scale, NPI‐D, PANAS, COPE‐PAC, PGI, QCPR. |
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Length and frequency of intervention | 1 session, 2 hours per week, for 12 weeks. After the weekly sessions, monthly sessions continued for 7 months, giving a possible 19 sessions over 10 months. | |
Time points measured | Baseline, 5 months' postrandomisation and 12 months postrandomisation. | |
Number of participants who did not complete study | 50/291 (17%); across all groups, including those not relevant to the current review. Specific attrition for each group not reported. | |
Notes | In group reminiscence sessions, family carers met separately from the main group for 45 minutes during 4 sessions, with the aim of developing listening and communication skills, and considering how the activities and strategies in the sessions could continue at home. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | A 2‐stage sequential dynamic algorithm was used to randomise participants. Randomisation was web based and was developed in collaboration with an accredited trials unit. |
Allocation concealment (selection bias) | Low risk | The combination of the 2 randomisation stages resulted in participant allocation. An (unblinded) administrator then informed carers of their allocation by letter. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | All research interviewers who assessed outcomes were blinded. After interview, researchers recorded their perceptions of participants' allocation. This showed no evidence of bias due to non‐blinded researchers. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | The authors reported "missing scores were imputed, with multiple imputations calculated using a linear regression model, taking into account demographic variables, treatment group and other scores provided at a given time point." Withdrawals due to carer time constraints, poor health of carer or relative with dementia. Specific dropouts from each group not reported. |
Selective reporting (reporting bias) | Low risk | All outcomes listed in the methods section and study protocol were reported. There was no evidence of selective outcome reporting. |
Other bias | Unclear risk | n/a. |
Availability of training and supervision Objective outcome measures | Low risk | Trial protocol reported "each group session is led by two experienced facilitators, supported by a team, including volunteers, health and social care staff and trainees to facilitate small group discussion and activities and engage the people with dementia. All members of the RYCT team attended a training day led by one of the original RYCT programme authors." |
Availability of manual or protocol for intervention All outcomes | Low risk | The group reminiscence intervention followed the RYCT programme for people with dementia and their family carers. |