Self-management in early-stage dementia: a pilot randomised controlled trial of the efficacy and cost-effectiveness of a self-management group intervention (the SMART study)

IntroductionJuvenile idiopathic arthritis (JIA) negatively affects adolescents’ everyday activities. To address the need for innovative, effective, convenient, low-cost psychosocial self-management programmes, we developed an Irish version of Canadian Teens Taking Charge (TTC) and integrated it with Skype-based peer support iPeer2Peer (iP2P).ObjectivesTo explore the feasibility and preliminary outcome impact (effectiveness) of an integrated iP2P and Irish TTC, via three-arm (treatment as usual, TTC and iP2P–TTC) pilot randomised controlled trial (RCT); and determine feasibility and sample size for a full RCT. To ensure active involvement of adolescents with JIA via a Young Person Advisory Panel and examine how participants experienced the study. Finally, to see if TTC and iP2P with TTC reduce costs for families.Methods and analysisRecruitment of 60 families will be ongoing until July 2019, via healthcare professionals and support groups. Analysis will consist of single-blinded (outcome assessment), three-arm pilot RCT, using online questionnaires, with assessments at baseline (T1), after intervention (T2) and 3 months post-intervention (T3). The primary outcomes on feasibility with comparisons of TTC and iP2P–TTC on fidelity, acceptability and satisfaction, engagement and degrees of tailoring. The secondary outcomes will be self-management and self-efficacy and a range of health-related quality-of-life factors, pain indicators and costs.Participants from the intervention groups will be invited to share their perspectives on the process in semistructured interviews. Quantitative data will be analysed using SPSS V.21 and the audio-taped and transcribed qualitative data will be analysed using qualitative content analysis.DisseminationVia journal articles, conference presentations, co-delivered by key stakeholders when possible, launch of accessible, effective and sustainable Internet self-management and peer support for Irish adolescents with JIA.Trial registration numberISRCTN13535901; Pre-results.

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Effectiveness and cost-effectiveness of a novel, group self-management course for adults with chronic musculoskeletal pain: study protocol for a multicentre, randomised controlled trial (COPERS)

BMJ Open ◽

10.1136/bmjopen-2012-002492 ◽

2013 ◽

Vol 3 (1) ◽

pp. e002492 ◽

Cited By ~ 7

Author(s):

Dawn Carnes ◽

Stephanie JC Taylor ◽

Kate Homer ◽

Sandra Eldridge ◽

Stephen Bremner ◽

...

Keyword(s):

Cost Effectiveness ◽

Randomised Controlled Trial ◽

Musculoskeletal Pain ◽

Study Protocol ◽

Controlled Trial ◽

Chronic Musculoskeletal Pain ◽

Self Management ◽

Randomised Controlled ◽

Group Self

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Correction: Protocol for an online randomised controlled trial to evaluate the clinical and cost-effectiveness of a peer-supported self-management intervention for relatives of people with psychosis or bipolar disorder: Relatives Education And Coping Toolkit (REACT)

BMJ Open ◽

10.1136/bmjopen-2017-016965corr1 ◽

2017 ◽

Vol 7 (9) ◽

pp. bmjopen-2017-016965corr1 ◽

Cited By ~ 1

Keyword(s):

Bipolar Disorder ◽

Cost Effectiveness ◽

Randomised Controlled Trial ◽

Controlled Trial ◽

Self Management ◽

Management Intervention ◽

Randomised Controlled ◽

And Coping

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Effectiveness and cost-effectiveness of a virtual multidisciplinary stroke care clinic for community-dwelling stroke survivors and caregivers: a randomised controlled trial protocol

BMJ Open ◽

10.1136/bmjopen-2018-026500 ◽

2019 ◽

Vol 9 (5) ◽

pp. e026500 ◽

Cited By ~ 2

Author(s):

Janita Pak Chun Chau ◽

Suzanne Hoi Shan Lo ◽

Vivian Wing Yan Lee ◽

Kai Chow Choi ◽

Edward Wai Ching Shum ◽

...

Keyword(s):

Cost Effectiveness ◽

Randomised Controlled Trial ◽

Controlled Trial ◽

Stroke Care ◽

Community Dwelling ◽

Self Management ◽

Care Clinic ◽

Emergency Admissions ◽

Randomised Controlled

IntroductionThe virtual multidisciplinary stroke care clinic (VMSCC) is the first nurse-led clinic developed to offer support to community-dwelling stroke survivors and caregivers, and to promote poststroke recovery. This two-arm randomised controlled trial will evaluate its effectiveness on survivors’ self-efficacy (SE), survivors’ and caregivers’ health-related quality of life (HRQoL) and cost-effectiveness on emergency admissions and length of readmission hospital stay.Methods and analysisA consecutive sample of 384 stroke survivor–caregiver dyads will be recruited from four hospitals. An online platform that embraces readily accessible and reliable information will be developed. Participants randomly assigned to the intervention group will receive usual care plus the VMSCC service. The service includes access to a tablet containing 30 videos demonstrating appropriate self-care strategies, communication with a registered nurse monthly through video and telephone calls and regular blood pressure monitoring. Primary outcomes include survivors’ SE in self-management and survivors’ and caregivers’ HRQoL. Secondary outcomes include survivors’ performance of self-management behaviours, depression and social participation; and caregivers’ coping strategies, satisfaction with caring and depression. Data will be collected at baseline, and at 3 and 6 months after commencing the intervention. Survivors’ and caregivers’ satisfaction with the service will be assessed at 6-month follow-up. Multivariable regressions and generalised estimating equations model will be conducted. Survivors’ emergency admissions and length of hospital stay will be evaluated during the 6-month follow-up period. Cost-effectiveness analysis will be performed on the average total cost incurred.DiscussionThe results will inform stakeholders about incorporating the VMSCC service into current stroke rehabilitation service.Ethics and disseminationThis protocol was approved by the Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee (CREC Ref. No.: 2017.660). All participants will provide written informed consent. Results will be disseminated through scientific publications, and presentations at local and international conferences.Trial registration numberChiCTR1800016101; Pre-results.

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Usual care and a self-management support programme versus usual care and a relaxation programme for people living with chronic headache disorders: a randomised controlled trial protocol (CHESS)

BMJ Open ◽

10.1136/bmjopen-2019-033520 ◽

2020 ◽

Vol 10 (4) ◽

pp. e033520 ◽

Cited By ~ 1

Author(s):

Shilpa Patel ◽

Felix Achana ◽

Dawn Carnes ◽

Sandra Eldridge ◽

David R Ellard ◽

...

Keyword(s):

Cost Effectiveness ◽

Randomised Controlled Trial ◽

Usual Care ◽

Chronic Headache ◽

Controlled Trial ◽

Self Management ◽

Management Support ◽

Support Programme ◽

Chronic Headaches ◽

Randomised Controlled

IntroductionChronic headaches are poorly diagnosed and managed and can be exacerbated by medication overuse. There is insufficient evidence on the non-pharmacological approaches to helping people living with chronic headaches.Methods and analysisChronic Headache Education and Self-management Study is a pragmatic randomised controlled trial to test the effectiveness and cost-effectiveness of a self-management education support programme on top of usual care for patients with chronic headaches against a control of usual care and relaxation. The intervention is a 2-day group course based on education, personal reflection and a cognitive behavioural approach, plus a nurse-led one-to-one consultation and follow-up over 8 weeks. We aim to recruit 689 participants (356 to the intervention arm and 333 to the control) from primary care and self-referral in London and the Midlands. The trial is powered to show a difference of 2.0 points on the Headache Impact Test, a patient-reported outcome measure at 12 months post randomisation. Secondary outcomes include health related quality of life, self-efficacy, social activation and engagement, anxiety and depression and healthcare utilisation. Outcomes are being measured at 4, 8 and 12 months. Cost-effectiveness will be expressed in terms of incremental cost per quality-adjusted life year gained.Ethics and disseminationThis trial will provide data on effectiveness and cost-effectiveness of a self-management support programme for chronic headaches. The results will inform commissioning of services and clinical practice. North West – Greater Manchester East Research Ethics Committee have approved the trial. The current protocol version is 3.6 date 7 March 2019.Trial registration numberISRCTN79708100.

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