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Pragmatic randomised controlled trial of a personalised intervention for carers of people requiring home oxygen therapy.

ABSTRACT: We used a pragmatic randomised controlled trial to evaluate a behavioural change strategy targeting carers of chronically hypoxaemic patients using long-term home oxygen therapy. Intervention group carers participated in personalised educational sessions focusing on motivating carers to take actions to assist patients. All patients received usual care. Effectiveness was measured through a composite event of patient survival to hospitalisation, residential care admission or death to 12 months. Secondary outcomes at baseline, 3, 6 and 12 months included carer and patient emotional and physical well-being. No difference between intervention (n = 100) and control (n = 97) patients was found for the composite outcome (hazard ratio (HR) 1.22, 95% confidence interval (CI) = 0.89, 1.68; p = 0.22). Improved fatigue, mastery, vitality and general health occurred in intervention group patients (all p values < 0.05). No benefits were seen in carer outcomes. Mortality was significantly higher in intervention patients (HR = 2.01, 95% CI = 1.00, 4.14; p = 0.05; adjusted for Australia-modified Karnofsky Performance Status), with a significant diagnosis-intervention interaction (p = 0.028) showing higher mortality in patients with COPD (HR 4.26; 95% CI = 1.60, 11.35) but not those with interstitial lung disease (HR 0.83; 95% CI = 0.28, 2.46). No difference was detected in the primary outcome, but patient mortality was higher when carers had received the intervention, especially in the most disabled patients. Trials examining behavioural change interventions in severe disease should stratify for functionality, and both risks and benefits should be independently monitored. Trial registration: Australian New Zealand Clinical Trials Registry (ACTRN12607000177459).

SUBMITTER: Frith P

PROVIDER: S-EPMC6945457 | biostudies-literature | 2020 Jan-Dec

REPOSITORIES: biostudies-literature

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Pragmatic randomised controlled trial of a personalised intervention for carers of people requiring home oxygen therapy.

Frith Peter P Sladek Ruth R Woodman Richard R Effing Tanja T Bradley Sandra S van Asten Suzanne S Jones Tina T Hnin Khin K Luszcz Mary M Cafarella Paul P Eckermann Simon S Rowett Debra D Phillips Paddy A PA

Chronic respiratory disease 20200101

We used a pragmatic randomised controlled trial to evaluate a behavioural change strategy targeting carers of chronically hypoxaemic patients using long-term home oxygen therapy. Intervention group carers participated in personalised educational sessions focusing on motivating carers to take actions to assist patients. All patients received usual care. Effectiveness was measured through a composite event of patient survival to hospitalisation, residential care admission or death to 12 months. Se ...[more]

PMID: 31903773

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Project description:BackgroundFamily carers play a crucial role in supporting the health and well-being of people with intellectual disabilities. Given their role and responsibilities, many family carers experience significant and ongoing stress and mental health difficulties. Programmes and interventions which provide training and support to family carers have been shown to have a positive impact on levels of stress and quality of life. However, these are often face to face which can create barriers to full participation. Online interventions have been shown to offer flexibility in delivery compared with traditional face-to-face approaches. The primary objective of this study is to determine the feasibility of delivering the Carers-ID online intervention, while the secondary outcome is improved mental health in family carers of people with intellectual disabilities.MethodsFamily carers (n = 120) will be randomised to receive the intervention (n = 60) or assigned to a wait-list control (n = 60) group. The intervention ( www.Carers-ID.com ) consists of 14 modules which cover topics including the following: promoting resilience, providing peer support, reducing anxiety, managing stress, accessing local supports and managing family conflict and information for siblings who are carers. The intervention has been co-produced with voluntary sector organisations and family carers and tested for acceptability. Primary outcomes for this study include acceptability and feasibility of the outcome measures, recruitment, participation and retention rates and effect sizes. Secondary outcomes will be completed at three time points (baseline, following intervention completion and 3 months after completion). These include the following: the Depression, Anxiety and Stress Scale, the Warwick-Edinburgh Mental Well-being Scale, the Resilience Scale and the Social Connectedness Scale Revised. Participants (n = 12) who have taken part in the intervention arm of the research will be invited to participate in semi-structured interviews as part of the process evaluation.DiscussionThe Carers-ID intervention provides an online resource for family carers to support their mental health and well-being and promote their resilience. It represents an affordable and accessible means of delivering such support. Testing the feasibility of the intervention and related trial procedures is required to determine whether a full-scale randomised controlled trial to evaluate the intervention's effectiveness is warranted.Trial registrationClinicalTrials.gov : NCT05737823.

Project description:IntroductionReducing length of hospital stay for stroke survivors often creates a shift in the responsibility of care towards informal carers. Adjustment to the caregiving process is experienced by many carers as overwhelming, complex and demanding and can have a detrimental impact on mental and physical health and well-being. National policy guidelines recommend that carers' needs are considered and addressed; despite this, few interventions have been developed and empirically evaluated. We developed a biopsychosocial intervention in collaboration with carers of stroke survivors. Our aim is to determine whether the intervention can be delivered in a group setting and evaluated using a randomised controlled trial (RCT).Methods and analysisFeasibility RCT and nested qualitative interview study. We aim to recruit up to 40 stroke carers within 1 year of the stroke onset. Carers are randomised to usual care or usual care plus biopsychosocial intervention. Each intervention group will consist of five stroke carers. The intervention will focus on: psychoeducation, psychological adjustment to stroke, strategies for reducing unwanted negative thoughts and emotions and problem-solving strategies. The main outcome is the feasibility of conducting an RCT. Carer outcomes at 6 months include: anxiety and depression, quality of life and carer strain. Data are also collected from stroke survivors at baseline and 6 months including: level of disability, anxiety and depression, and quality of life.Ethics and disseminationFavourable ethical opinion was provided by East Midlands - Nottingham2 Research Ethics Committee (14/EMI/1264). This study will determine whether delivery of the biopsychosocial intervention is feasible and acceptable to stroke carers within a group format. It will also determine whether it is feasible to evaluate the effects of the biopsychosocial intervention in an RCT. We will disseminate our findings through peer-reviewed publications and presentations at national and international conferences.Trial registration numberISRCTN15643456; Pre-results.

Project description:BackgroundEvidence-based rehabilitative interventions, if widely implemented, could equip people with dementia and their families to manage life with the condition and reduce the need for health and care services. The aim of this translational study, building on evidence from the GREAT randomised controlled trial, was to develop a foundation for implementing the GREAT Cognitive Rehabilitation intervention in community-based services for people with mild-to-moderate dementia.MethodsKey elements of the implementation strategy were identifying and supporting managerial and clinical leadership, conducting collaborative planning and target-setting, training and supporting practitioners, and providing external facilitation. We developed implementation plans with, and trained staff in, 14 organisations. We subsequently worked closely with 11 of these, 10 National Health Service organisations and one private home care provider, to support practitioners to deliver GREAT Cognitive Rehabilitation over a 12-month period. Outcome evaluation examined the perspectives of local steering group members, practitioners and service users, and the reach, effectiveness and cost of the intervention.ResultsImplementation was disrupted by the COVID-19 pandemic, but six organisations completed at least six months of intervention delivery. Forty-one practitioners, mainly occupational therapists, provided the intervention, and 54 people with dementia completed a course of GREAT Cognitive Rehabilitation. Goal attainment by people with dementia exceeded levels of improvement seen in the original trial. People with dementia, carers, practitioners and steering group members all evaluated the intervention positively, and economic analysis indicated that the intervention could be provided at modest cost. However, we identified a range of mainly organisational barriers that impeded implementation and limited the potential for sustainability.ConclusionsGREAT Cognitive Rehabilitation benefits people with dementia, can be delivered effectively at modest cost in routine services, and is viewed positively by people with dementia, family carers and practitioners. To fully realise these benefits and achieve widespread and sustainable implementation, however, requires sufficient resources and a reorientation of service priorities towards preventive and rehabilitative approaches.Trial registrationNational Institute for Health Research (NIHR) Central Portfolio Management System, registration number 38994.

Project description:BackgroundFew data on services for people with severe multiple sclerosis (MS) are available. The Palliative Network for Severely Affected Adults with MS in Italy (PeNSAMI) developed a home palliative care program for MS patients and carers, preceded by a literature review and qualitative study (here reported).ObjectiveTo identify unmet needs of people with severe MS living at home by qualitative research involving key stakeholders, and theorize broad areas of intervention to meet those needs.MethodData were collected from: at least 10 personal interviews with adults with severe MS (primary/secondary progressive, EDSS≥8.0); three focus group meetings (FGs) of carers of people with severe MS; and two FGs of health professionals (HPs). Grounded theory guided the analysis of interview and FG transcripts, from which the areas of intervention were theorized.ResultsBetween October 2012 and May 2013, 22 MS patients, 30 carers and 18 HPs participated. Forty-eight needs themes were identified, grouped into 14 categories and four domains. Seven, highly interdependent intervention areas were theorized. Patients had difficulties expressing needs; experiences of burden and loneliness were prominent, chiefly in dysfunctional, less affluent families, and among parent carers. Needs differed across Italy with requirements for information and access to services highest in the South. All participants voiced a strong need for qualified personnel and care coordination in day-to-day home care. Personal hygiene emerged as crucial, as did the need for a supportive network and preservation of patient/carer roles within family and community.ConclusionsUnmet needs transcended medical issues and embraced organizational and psychosocial themes, as well as health policies. The high interdependence of the seven intervention areas theorized is in line with the multifaceted approach of palliative care. At variance with typical palliative contexts, coping with disability rather than end-of-life was a major concern of patients and carers.

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:BackgroundParent carers of children with special educational needs or disability are at higher risk of poor mental and physical health. The need for a tailored, peer-led group programme was raised by parent carers, who co-developed the Healthy Parent Carers programme with researchers. This study aimed to test the feasibility of programme delivery in community settings, and the feasibility and acceptability of a randomised controlled trial design.MethodsParticipants were individually randomised with concealed allocation to a structured group programme and access to online resources (intervention), or access to the online resources only (control). Measures of wellbeing and secondary and economic outcomes were collected before randomisation, immediately post-intervention, and 6 months post-intervention. Descriptive statistics on recruitment and attrition, demographics, attendance, and fidelity of intervention delivery were analysed with feedback on the acceptability of the trial design.ResultsOne hundred and ninety-three parent carers expressed an interest in taking part. Ninety-two participants recruited from across six sites were randomised (47 intervention, 45 control). Lead and assistant facilitators were trained and delivered the group sessions. Sixteen (34%) participants in the intervention arm did not attend any sessions, and attendance varied across sites and sessions. One participant withdrew post-randomisation, and 83 (90%) participants completed outcome measures at the six-month follow-up.ConclusionsThe study demonstrated that it was feasible to deliver the programme in community settings. The number of parent carers who expressed interest signifies the need for such a programme and the feasibility of recruiting to a definitive trial. Loss to follow-up was low. Further research is needed to explore ways to reduce barriers to participation in person and assess the feasibility and acceptability of programme content and delivery for more ethnically diverse groups, and potentially using interpreters. Given the Covid-19 pandemic and delivery format feedback, there is also a need to investigate remote or blended delivery strategies. Although the results indicate that a definitive trial is feasible, programme impact would be strengthened through exploration of these uncertainties.Trial registrationISRCTN, ISRCTN15144652 , registered on 25 October 2018, ClinicalTrials.gov , NCT03705221 , registered on 15 October 2018.

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Pragmatic randomised controlled trial of a personalised intervention for carers of people requiring home oxygen therapy.

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Pragmatic randomised controlled trial of a personalised intervention for carers of people requiring home oxygen therapy.

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