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

TY - JOUR

T1 - Digital peer-to-peer support programme for informal caregivers of people living with motor neuron disease

T2 - study protocol for a multi-centre parallel group, single-blinded (outcome assessor) randomised controlled superiority trial

AU - Rose, Louise

AU - Thaventhiran, Thilipan

AU - Hobson, Esther

AU - Rogers, Rebecca

AU - James, Kirsty

AU - Chu, Petrina

AU - Carter, Ben

AU - Faull, Christina

AU - Saha, Sian

AU - Lee, Jeong Su

AU - Kaltsakas, Georgios

AU - McDermott, Christopher

AU - Ramsay, Michelle

N1 - © 2023. The Author(s). Funding Information: We acknowledge the contributions of the caregivers who participate in this research during a time of exceptional challenge in their lives. This study would not be possible without volunteer peer supporters and participating PIC sites. CJM is supported by the NIHR Sheffield Biomedical Research Centre and the NIHR RP programme. Funding Information: The study was funded by the Marie Curie Charity in association with the UK MND Association. Publisher Copyright: © 2023, The Author(s).

PY - 2023/2/20

Y1 - 2023/2/20

N2 - Background: Peer 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. Methods: We 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. Discussion: This 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 registration: ClinicalTrials.gov:

AB - Background: Peer 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. Methods: We 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. Discussion: This 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 registration: ClinicalTrials.gov:

KW - Amyotrophic lateral sclerosis

KW - Informal caregiver

KW - Motor Neuron Disease

KW - Peer support

KW - Randomised controlled trial

KW - e-Health

UR - http://www.scopus.com/inward/record.url?scp=85148391546&partnerID=8YFLogxK

U2 - 10.1186/s13063-023-07124-3

DO - 10.1186/s13063-023-07124-3

M3 - Article

C2 - 36805758

SN - 1745-6215

VL - 24

JO - Trials

JF - Trials

IS - 1

M1 - 119

ER -