Digital peer-to-peer support programme for informal caregivers of people living with motor neuron disease: study protocol for a multi-centre parallel group, single-blinded (outcome assessor) randomised controlled superiority trial

Trials

Study Protocol

Ben Carter¹  Petrina Chu¹  Kirsty James¹  Rebecca Rogers²  Thilipan Thaventhiran²  Louise Rose³  Sian Saha⁴  Christina Faull⁵  Michelle Ramsay⁶  Jeong Su Lee⁶  Georgios Kaltsakas⁷  Christopher McDermott⁸  Esther Hobson⁸ 

[1] Department of Biostatistics and Health Informatics, Institute of Psychiatry, King’s College London, Psychology & NeuroscienceDe Crespigny Park, SE5 8AF, London, United Kingdom;Florence Nightingale Faculty of Nursing, Midwifery and Palliative Care, King’s College London, James Clerk Maxwell Building, SE1 8WA, London, United Kingdom;Florence Nightingale Faculty of Nursing, Midwifery and Palliative Care, King’s College London, James Clerk Maxwell Building, SE1 8WA, London, United Kingdom;Lane Fox Respiratory Service, Guy’s and St Thomas’ NHS Foundation Trust, Westminster Bridge Rd, SE17HE, London, United Kingdom;King’s College Hospital, Denmark Hill, SE59RS, London, United Kingdom;LOROS Hospice, Groby Rd, LE39QE, Leicester, United Kingdom;Lane Fox Respiratory Service, Guy’s and St Thomas’ NHS Foundation Trust, Westminster Bridge Rd, SE17HE, London, United Kingdom;Lane Fox Respiratory Service, Guy’s and St Thomas’ NHS Foundation Trust, Westminster Bridge Rd, SE17HE, London, United Kingdom;Centre for Human and Applied Physiological Sciences (CHAPS), King’s College London, SE1 8WA, London, United Kingdom;Sheffield Institute for Translational Neuroscience, University of Sheffield, 385a Glossop Rd, S102HQ, Sheffield, United Kingdom;

关键词: Peer support;    Motor neuron disease;    Amyotrophic lateral sclerosis;    Informal caregiver;    e-Health;    Randomised controlled trial;   

DOI  :  10.1186/s13063-023-07124-3

 received in 2022-11-22, accepted in 2023-01-28,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundPeer support is effective in improving psychological well-being of family caregivers of people with conditions such as dementia, cancer, and brain injury. However, there are limited data on effective psychological interventions for family caregivers of people living with motor neurone disease. Our objective is to evaluate the efficacy of a virtual peer support programme for improving caregiver psychological wellbeing and caregiving related outcomes.MethodsWe will conduct a multi-centre parallel group randomised controlled superiority trial. Using a multi-modal recruitment strategy, we will recruit informal caregivers from UK MND clinics, in-patient units, and hospices. We will randomise (1:1, stratified by gender) participants to either a 12-week virtual peer support programme or usual care comprising provision of online information resources publicly available via the MND Association website. Peer support programme elements will be delivered via a secure digital e-platform aTouchAway™ (Aetonix, Canada). Our target sample size is 160 (80 each arm). Our primary outcome is the Hospital Anxiety and Depression Scale (HADS) assessed at 12 weeks (primary endpoint). Secondary outcomes that will also be assessed at 12 weeks include the Zarit Burden Interview, Pearlin Mastery Scale, Personal Gain Scale, Positive Affect Scale, and the Brief COPE. Outcome assessors will be blinded to allocation. Tertiary outcomes include perceived usability (1 item 9-point Likert scale) and acceptability (semi-structured qualitative interviews) of the peer support programme. Intervention fidelity measures will comprise frequency, type (text, audio, video), and duration (audio and video) of peer support contact downloaded from the aTouchAway AWS server. We will use a mixed-effects linear model to test the effect of the intervention on the primary outcome. Secondary outcomes will be analysed using linear regression. We have ethical approval (21/NW/0269) from the North-West Research Ethics Committee, UK.DiscussionThis single-blinded randomised controlled trial will determine the effect of a virtual peer support programme on caregiver psychological wellbeing and caregiver burden. This study will examine the impact of a virtual peer support intervention on quality-of-life measures in informal caregivers of individuals with MND living in the community.Trial registrationClinicalTrials.gov: NCT04695210

【 授权许可】

CC BY   
© The Author(s) 2023

【 图 表 】

Fig. 7

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