Dataset Information

Clinical effectiveness of a manual based coping strategy programme (START, STrAtegies for RelaTives) in promoting the mental health of carers of family members with dementia: pragmatic randomised controlled trial.

ABSTRACT:

Objective

To assess whether a manual based coping strategy compared with treatment as usual reduces depression and anxiety symptoms in carers of family members with dementia.

Design

Randomised, parallel group, superiority trial.

Setting

Three mental health community services and one neurological outpatient dementia service in London and Essex, UK.

Participants

260 carers of family members with dementia.

Intervention

A manual based coping intervention comprising eight sessions and delivered by supervised psychology graduates to carers of family members with dementia. The programme consisted of psychoeducation about dementia, carers' stress, and where to get emotional support; understanding behaviours of the family member being cared for, and behavioural management techniques; changing unhelpful thoughts; promoting acceptance; assertive communication; relaxation; planning for the future; increasing pleasant activities; and maintaining skills learnt. Carers practised these techniques at home, using the manual and relaxation CDs.

Main outcome measures

Affective symptoms (hospital anxiety and depression total score) at four and eight months. Secondary outcomes were depression and anxiety caseness on the hospital anxiety and depression scale; quality of life of both the carer (health status questionnaire, mental health) and the recipient of care (quality of life-Alzheimer's disease); and potentially abusive behaviour by the carer towards the recipient of care (modified conflict tactics scale).

Results

260 carers were recruited; 173 were randomised to the intervention and 87 to treatment as usual. Mean total scores on the hospital anxiety and depression scale were lower in the intervention group than in the treatment as usual group over the eight month evaluation period: adjusted difference in means -1.80 points (95% confidence interval -3.29 to -0.31; P=0.02) and absolute difference in means -2.0 points. Carers in the intervention group were less likely to have case level depression (odds ratio 0.24, 95% confidence interval 0.07 to 0.76) and there was a non-significant trend towards reduced case level anxiety (0.30, 0.08 to 1.05). Carers' quality of life was higher in the intervention group (difference in means 4.09, 95% confidence interval 0.34 to 7.83) but not for the recipient of care (difference in means 0.59, -0.72 to 1.89). Carers in the intervention group reported less abusive behaviour towards the recipient of care compared with those in the treatment as usual group (odds ratio 0.47, 95% confidence interval 0.18 to 1.23), although this was not significant.

Conclusions

A manual based coping strategy was effective in reducing affective symptoms and case level depression in carers of family members with dementia. The carers' quality of life also improved.

Trial registration

Current Controlled Trials ISCTRN70017938.

SUBMITTER: Livingston G

PROVIDER: S-EPMC3808082 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:ObjectiveTo assess whether the START (STrAtegies for RelatTives) intervention added to treatment as usual is cost effective compared with usual treatment alone.DesignCost effectiveness analysis nested within a pragmatic randomised controlled trial.SettingThree mental health and one neurological outpatient dementia service in London and Essex, UK.ParticipantsFamily carers of people with dementia.InterventionEight session, manual based, coping intervention delivered by supervised psychology graduates to family carers of people with dementia added to usual treatment, compared with usual treatment alone.Primary outcome measuresCosts measured from a health and social care perspective were analysed alongside the Hospital Anxiety and Depression Scale total score (HADS-T) of affective symptoms and quality adjusted life years (QALYs) in cost effectiveness analyses over eight months from baseline.ResultsOf the 260 participants recruited to the study, 173 were randomised to the START intervention, and 87 to usual treatment alone. Mean HADS-T scores were lower in the intervention group than the usual treatment group over the 8 month evaluation period (mean difference -1.79 (95% CI -3.32 to -0.33)), indicating better outcomes associated with the START intervention. There was a small improvement in health related quality of life as measured by QALYs (0.03 (-0.01 to 0.08)). Costs were no different between the intervention and usual treatment groups (£252 (-28 to 565) higher for START group). The cost effectiveness calculations suggested that START had a greater than 99% chance of being cost effective compared with usual treatment alone at a willingness to pay threshold of £30,000 per QALY gained, and a high probability of cost effectiveness on the HADS-T measure.ConclusionsThe manual based coping intervention START, when added to treatment as usual, was cost effective compared with treatment as usual alone by reference to both outcome measures (affective symptoms for family carers, and carer based QALYs).Trial registrationISCTRN 70017938.

Project description:OBJECTIVES:To analyse the experience of individual family carers of people with dementia who received a manual-based coping strategy programme (STrAtegies for RelaTives, START), demonstrated in a randomised-controlled trial to reduce affective symptoms. DESIGN:A qualitative study using self-completed questionnaires exploring the experience of the START intervention. Two researchers transcribed, coded and analysed completed questionnaires thematically. SETTING:Three mental health and one neurology dementia clinic in South East England. PARTICIPANTS:Participants were primary family carers of a patient diagnosed with dementia who provided support at least weekly to their relative. We invited those in the treatment group remaining in the START study at 2?years postrandomisation (n=132) to participate. 75 people, comprising a maximum variation sample, responded. PRIMARY AND SECONDARY OUTCOME MEASURES:(1) Important aspects of the therapy. (2) Continued use of the intervention after the end of the therapy. (3) Unhelpful aspects of the therapy and suggestions for improvement. (4) Appropriate time for intervention delivery. RESULTS:Carers identified several different components as important: relaxation techniques, education about dementia, strategies to help manage the behaviour of the person with dementia, contact with the therapist and changing unhelpful thoughts. Two-thirds of the participants reported that they continue to use the intervention's techniques at 2-year follow up. Few participants suggested changes to the intervention content, but some wanted more sessions and others wanted the involvement of more family members. Most were happy with receiving the intervention shortly after diagnosis, although some relatives of people with moderate dementia thought it should have been delivered at an earlier stage. CONCLUSIONS:Participants' varied responses about which aspects of START were helpful suggest that a multicomponent intervention is suited to the differing circumstances of dementia carers, providing a range of potentially helpful strategies. The continued use of the strategies 2?years after receiving the intervention could be a mechanism for the intervention remaining effective.

Project description:Family members remain the main care providers for the increasing numbers of people with dementia, and often become depressed or anxious. In an implementation research project, we aimed to widen access to Strategies for RelaTives (START), a clinically and cost-effective intervention for the mental health of family carers, by laying the foundations for its implementation in the third sector. We used the integrated Promoting Action on Research Implementation in Health Services (i-PARIHS) framework to guide implementation of START, a manual-based, individually-delivered, multicomponent eight-session coping strategy intervention. We interviewed a maximum variation sample of twenty-seven stakeholders from the English Alzheimer's Society (AS), about possible difficulties in management, training, and delivery of START. We trained and supervised three AS dementia support workers in different locations, to each deliver START to three family carers. Two researchers independently coded pre-intervention interviews for themes. We assessed intervention feasibility through monitoring delivery fidelity, rating audio-recordings from 1-5 (5 being high) and interviewing facilitators, family carers and AS managers about their experiences. We assessed effectiveness on family carers' mental health using the Hospital Anxiety and Depression Scale (HADS) before and after receiving START (scores 0-42). We changed START's format by reflecting carer diversity more and increasing carer stories prominence, but core content or delivery processes were unchanged. All carers received START and attended every session. The mean fidelity score was 4.2. Mean HADS-total score reduced from baseline 18.4 (standard deviation 7.4) to follow-up 15.8 (9.7). Six (67%) carers scored as clinically depressed on baseline HADS and 2 (22%) at follow-up. Facilitators and carers rated START positively. Appropriately experienced third sector workers can be trained and supervised to deliver START and it remains effective. This has the potential for widened access at scale.

Project description:BackgroundJoint 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.MethodsThis 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.ResultsThe 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.ConclusionsThis 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 registrationISRCTN Registry ISRCTN42430123.

Project description:National guidance for chronic obstructive pulmonary disease (COPD) suggests that self-management support be provided for patients. Our institution has developed a standardised, manual-based, supported self-management programme: Self-Management Programme of Activity Coping and Education (SPACE for COPD(C)). SPACE was previously piloted on a 1-2-1 basis, delivered by researchers, to individuals with COPD. Discussions with stakeholders highlighted considerable interest in delivering the SPACE for COPD(C) intervention as a group-based self-management programme facilitated by healthcare professionals (HCPs) in primary care settings. The study aims are to explore the feasibility, acceptability and efficacy for the intervention to be delivered and supported by HCPs and to examine whether group-based delivery of SPACE for COPD(C), with sustained support, improves patient outcomes following the SPACE for COPD(C) intervention.A prospective, multi-site, single-blinded randomised controlled trial (RCT) will be conducted, with follow-up at 6 and 9 months. Participants will be randomly assigned to either the control group (usual care) or intervention group (a six-session, group-based SPACE for COPD(C)self-management programme delivered over 5 months). The primary outcome is change in COPD assessment test at 6?months.A discussion session will be conducted with HCPs who deliver the intervention to discuss and gain insight into any potential facilitators/barriers to implementing the intervention in practice. Furthermore, we will conduct semi-structured focus groups with intervention participants to understand feasibility and acceptability. All qualitative data will be analysed thematically.The project has received a favourable opinion from South Hampshire B Research Ethics Committee, REC reference: 14/SC/1169 and full R&D approval from the University Hospitals of Leicester NHS Trust: 152408.Study results will be disseminated through appropriate peer-reviewed journals, national and international respiratory/physiotherapy conferences, via the Collaboration and Leadership in Applied Health Research and Care and through social media.ISRCTN17942821; pre-results.

Project description:BACKGROUND:My Tools 4 Care (MT4C) is a Web-based intervention that was developed based on the transitions theory. It is an interactive, self-administered, and portable toolkit containing six main sections intended to support carers of community-living persons with Alzheimer's disease and related dementia and multiple chronic conditions through their transition experiences. OBJECTIVE:The objective of our study was to evaluate the effectiveness of MT4C with respect to increasing hope, self-efficacy, and health-related quality of life in carers of community-living older persons with Alzheimer's disease and related dementia and multiple chronic conditions. METHODS:A multisite, pragmatic, mixed methods, longitudinal, repeated-measures, randomized controlled trial was conducted between June 2015 and April 2017. Eligible participants were randomized into either treatment (MT4C) or educational control groups. Following baseline measures, carers in the treatment group received 3 months of password-protected access to MT4C. Trained research assistants collected data from participants via phone on hope (Herth Hope Index [HHI]), self-efficacy (General Self-Efficacy Scale), and health-related quality of life (Short Form-12 item [version 2] health survey; SF-12v2) at baseline, 1, 3, and 6 months. The use and cost of health and social services (Health and Social Services Utilization Inventory) among participants were measured at baseline, 3, and 6 months. Analysis of covariance was used to identify group differences at 3 months, and generalized estimating equations were used to identify group differences over time. RESULTS:A total of 199 carers participated in this study, with 101 participants in the treatment group and 98 in the educational control group. Of all, 23% (45/199) participants withdrew during the study for various reasons, including institutionalization or death of the person with dementia and lack of time from the carer. In the treatment group, 73% (74/101) carers used MT4C at least once over the 3-month period. No significant differences in the primary outcome measure (mental component summary score from the SF-12v2) by group or time were noted at 3 months; however, significant differences were evident for HHI-factor 2 (P=.01), with higher hope scores in the treatment group than in the control group. General estimating equations showed no statistically significant group differences in terms of mental component summary score at all time points. Attrition and the fact that not all carers in the treatment group used MT4C may explain the absence of statistically significant results for the main outcome variable. CONCLUSIONS:Despite no significant differences between groups in terms of the primary outcome variable (mental component score), the significant differences in terms of one of the hope factors suggest that MT4C had a positive influence on the lives of participants. TRIAL REGISTRATION:ClinicalTrials.gov NCT02428387; https://clinicaltrials.gov/ct2/show/NCT02428387 (Archived by Webcite at http://www.webcitation.org/708oFCR8h).