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REMCARE: Pragmatic Multi-Centre Randomised Trial of Reminiscence Groups for People with Dementia and their Family Carers: Effectiveness and Economic Analysis.

Woods RT, Orrell M, Bruce E, Edwards RT, Hoare Z, Hounsome B, Keady J, Moniz-Cook E, Orgeta V, Rees J, Russell I - PLoS ONE (2016)

Bottom Line: This study aimed to assess the effectiveness and cost-effectiveness of joint reminiscence groups as compared to usual care.Economic analyses from a public sector perspective indicated that joint reminiscence groups are unlikely to be cost-effective.There were no significant adverse effects attributed to the intervention.

View Article: PubMed Central - PubMed

Affiliation: Dementia Services Development Centre Wales, Bangor University, Bangor, Gwynedd, United Kingdom.

ABSTRACT

Background: Joint reminiscence groups, involving people with dementia and family carers together, are popular, but the evidence-base is limited. This study aimed to assess the effectiveness and cost-effectiveness of joint reminiscence groups as compared to usual care.

Methods: This multi-centre, pragmatic randomised controlled trial had two parallel arms: intervention group and usual-care control group. A restricted dynamic method of randomisation was used, with an overall allocation ratio of 1:1, restricted to ensure viable sized intervention groups. Assessments, blind to treatment allocation, were carried out at baseline, three months and ten months (primary end-point), usually in the person's home. Participants were recruited in eight centres, mainly through NHS Memory Clinics and NHS community mental health teams. Included participants were community resident people with mild to moderate dementia (DSM-IV), who had a relative or other care-giver in regular contact, to act as informant and willing and able to participate in intervention. 71% carers were spouses. 488 people with dementia (mean age 77.5)were randomised: 268 intervention, 220 control; 350 dyads completed the study (206 intervention, 144 control). The intervention evaluated was joint reminiscence groups (with up to 12 dyads) weekly for twelve weeks; monthly maintenance sessions for further seven months. Sessions followed a published treatment manual and were held in a variety of community settings. Two trained facilitators in each centre were supported by volunteers. Primary outcome measures were self-reported quality of life for the person with dementia (QoL-AD), psychological distress for the carer (General Health Questionnaire, GHQ-28). Secondary outcome measures included: autobiographical memory and activities of daily living for the person with dementia; carer stress for the carer; mood, relationship quality and service use and costs for both.

Results: The intention to treat analysis (ANCOVA) identified no differences in outcome between the intervention and control conditions on primary or secondary outcomes (self-reported QoL-AD mean difference 0.07 (-1.21 to 1.35), F = 0.48, p = 0.53). Carers of people with dementia allocated to the reminiscence intervention reported a significant increase in anxiety on a General Health Questionnaire-28 sub-scale at the ten month end-point (mean difference 1.25 (0.25 to 2.26), F = 8.28, p = 0.04). Compliance analyses suggested improved autobiographical memory, quality of life and relationship quality for people with dementia attending more reminiscence sessions, however carers attending more groups showed increased care-giving stress. Economic analyses from a public sector perspective indicated that joint reminiscence groups are unlikely to be cost-effective. There were no significant adverse effects attributed to the intervention. Potential limitations of the study include less than optimal attendance at the group sessions--only 57% of participants attended at least half of the intervention sessions over the 10 month period, and a higher rate of study withdrawal in the control group.

Conclusions: This trial does not support the clinical effectiveness or cost-effectiveness of joint reminiscence groups. Possible beneficial effects for people with dementia who attend sessions as planned are offset by raised anxiety and stress in their carers. The reasons for these discrepant outcomes need to be explored further, and may necessitate reappraisal of the movement towards joint interventions.

Trial registration: ISRCTN Registry ISRCTN42430123.

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Related in: MedlinePlus

Consort diagram of participant flow through study.
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pone.0152843.g001: Consort diagram of participant flow through study.

Mentions: The design was a pragmatic eight-centre randomised trial (Fig 1) with two parallel arms: an intervention group, and a control group receiving care as usual. Assessments, blind to treatment allocation, were carried out at baseline, three months and ten months (the primary end point). Randomisation used a dynamic allocation method [11] stratifying for spousal or non-spousal relationship of the dyad. Complete list randomisation for each wave of recruitment within each centre was completed. Randomisation was carried out remotely by the NWORTH accredited Clinical Trials Unit, initiated by a local researcher who did not take part in follow-up assessments. This researcher arranged for those pairs (up to 12) randomised to the intervention group to attend sessions, and liaised with the group facilitator. Though participants could not be blinded to their allocated treatment, all follow-up data were gathered by blinded interviewers. In order to reduce the risk of participants occasionally and inadvertently unblinding researchers, explicit reminders were given to participants before assessment visits and self-report measures were used wherever feasible. Assessors were also asked to record their impression of the arm to which each participant belonged so that any bias could be detected. A favourable ethical opinion was given by the Multi-centre Research Ethics Committee for Wales (ref no. 07/MRE09/58).


REMCARE: Pragmatic Multi-Centre Randomised Trial of Reminiscence Groups for People with Dementia and their Family Carers: Effectiveness and Economic Analysis.

Woods RT, Orrell M, Bruce E, Edwards RT, Hoare Z, Hounsome B, Keady J, Moniz-Cook E, Orgeta V, Rees J, Russell I - PLoS ONE (2016)

Consort diagram of participant flow through study.
© Copyright Policy
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4836678&req=5

pone.0152843.g001: Consort diagram of participant flow through study.
Mentions: The design was a pragmatic eight-centre randomised trial (Fig 1) with two parallel arms: an intervention group, and a control group receiving care as usual. Assessments, blind to treatment allocation, were carried out at baseline, three months and ten months (the primary end point). Randomisation used a dynamic allocation method [11] stratifying for spousal or non-spousal relationship of the dyad. Complete list randomisation for each wave of recruitment within each centre was completed. Randomisation was carried out remotely by the NWORTH accredited Clinical Trials Unit, initiated by a local researcher who did not take part in follow-up assessments. This researcher arranged for those pairs (up to 12) randomised to the intervention group to attend sessions, and liaised with the group facilitator. Though participants could not be blinded to their allocated treatment, all follow-up data were gathered by blinded interviewers. In order to reduce the risk of participants occasionally and inadvertently unblinding researchers, explicit reminders were given to participants before assessment visits and self-report measures were used wherever feasible. Assessors were also asked to record their impression of the arm to which each participant belonged so that any bias could be detected. A favourable ethical opinion was given by the Multi-centre Research Ethics Committee for Wales (ref no. 07/MRE09/58).

Bottom Line: This study aimed to assess the effectiveness and cost-effectiveness of joint reminiscence groups as compared to usual care.Economic analyses from a public sector perspective indicated that joint reminiscence groups are unlikely to be cost-effective.There were no significant adverse effects attributed to the intervention.

View Article: PubMed Central - PubMed

Affiliation: Dementia Services Development Centre Wales, Bangor University, Bangor, Gwynedd, United Kingdom.

ABSTRACT

Background: Joint reminiscence groups, involving people with dementia and family carers together, are popular, but the evidence-base is limited. This study aimed to assess the effectiveness and cost-effectiveness of joint reminiscence groups as compared to usual care.

Methods: This multi-centre, pragmatic randomised controlled trial had two parallel arms: intervention group and usual-care control group. A restricted dynamic method of randomisation was used, with an overall allocation ratio of 1:1, restricted to ensure viable sized intervention groups. Assessments, blind to treatment allocation, were carried out at baseline, three months and ten months (primary end-point), usually in the person's home. Participants were recruited in eight centres, mainly through NHS Memory Clinics and NHS community mental health teams. Included participants were community resident people with mild to moderate dementia (DSM-IV), who had a relative or other care-giver in regular contact, to act as informant and willing and able to participate in intervention. 71% carers were spouses. 488 people with dementia (mean age 77.5)were randomised: 268 intervention, 220 control; 350 dyads completed the study (206 intervention, 144 control). The intervention evaluated was joint reminiscence groups (with up to 12 dyads) weekly for twelve weeks; monthly maintenance sessions for further seven months. Sessions followed a published treatment manual and were held in a variety of community settings. Two trained facilitators in each centre were supported by volunteers. Primary outcome measures were self-reported quality of life for the person with dementia (QoL-AD), psychological distress for the carer (General Health Questionnaire, GHQ-28). Secondary outcome measures included: autobiographical memory and activities of daily living for the person with dementia; carer stress for the carer; mood, relationship quality and service use and costs for both.

Results: The intention to treat analysis (ANCOVA) identified no differences in outcome between the intervention and control conditions on primary or secondary outcomes (self-reported QoL-AD mean difference 0.07 (-1.21 to 1.35), F = 0.48, p = 0.53). Carers of people with dementia allocated to the reminiscence intervention reported a significant increase in anxiety on a General Health Questionnaire-28 sub-scale at the ten month end-point (mean difference 1.25 (0.25 to 2.26), F = 8.28, p = 0.04). Compliance analyses suggested improved autobiographical memory, quality of life and relationship quality for people with dementia attending more reminiscence sessions, however carers attending more groups showed increased care-giving stress. Economic analyses from a public sector perspective indicated that joint reminiscence groups are unlikely to be cost-effective. There were no significant adverse effects attributed to the intervention. Potential limitations of the study include less than optimal attendance at the group sessions--only 57% of participants attended at least half of the intervention sessions over the 10 month period, and a higher rate of study withdrawal in the control group.

Conclusions: This trial does not support the clinical effectiveness or cost-effectiveness of joint reminiscence groups. Possible beneficial effects for people with dementia who attend sessions as planned are offset by raised anxiety and stress in their carers. The reasons for these discrepant outcomes need to be explored further, and may necessitate reappraisal of the movement towards joint interventions.

Trial registration: ISRCTN Registry ISRCTN42430123.

Show MeSH
Related in: MedlinePlus