Virtual Peer-to-peer Support Programme for Carers of MND
NCT ID: NCT04695210
Last Updated: 2024-10-22
Study Results
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Basic Information
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RECRUITING
NA
154 participants
INTERVENTIONAL
2022-08-15
2025-07-31
Brief Summary
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Despite the recognized impact of caregiving for individuals with MND, data are scarce as to effective interventions that provide direct practical and psychosocial supports. Difficulty accessing support may increase psychological distress. As the burden of caring increases due to disease progression and increasing technology dependence, access to existing informal support networks may diminish. Online peer support using virtual modalities is a flexible and low cost form of support. Peers, people who have experienced the same health problem and have similar characteristics as support recipients, can be a key source of emotional, informational, and affirmational support. Peer support improves psychological well-being of caregivers of people with conditions such as dementia, cancer, and brain injury. Although peer support programmes for family caregivers of people with MND exist, data as to their efficacy are limited. Therefore, we have developed an online peer support programme, completed beta and usability testing and now propose to test the effect on caregiver psychological wellbeing and caregiver burden.
Aim/research question(s) Overall aim: to determine the efficacy of a 12-week online peer support programme on family caregiver psychological health and caregiver burden.
Primary research question:
What is the effect of the online peer support programme on psychological distress measured using the Hospital Anxiety and Depression Scale (HADS)?
Secondary research questions:
1. What is the effect on positive affect, caregiver burden, caregiving mastery, caregiving personal gain, and coping?
2. How do participants use the programme (fidelity and reach)?
3. What is the perceived usability and acceptability?
Methods The investigators will conduct a parallel group randomised controlled trial with participants allocated to 12-week access to the online peer support programme or a usual care control group. The investigators will enrol family caregivers of an individual with MND who is referred for consideration or receiving any of the following
1. assisted ventilation
2. cough assist
3. gastroscopy and enteral feeding
i.e., entering King's clinical staging Stage 4A: nutritional support; or Stage 4B: respiratory support \[51\]:
The 12-week peer-to-peer support programme entails:
1. audio, video, or text private messaging;
2. synchronous weekly chat;
3. asynchronous discussion forum; and
4. informational resources.
The investigators will collect demographic and caregiving data including the Caregiver Assistance Scale and Caregiving Impact Scale, and caregiver measures (HADS, Positive and Negative Affect Schedule, Zarit Burden Interview, Pearlin Mastery Scale, Personal Gain Scale, Brief COPE) at baseline and programme completion.
The investigators will download use of online peer support programme features, assess usability, and conduct semi-structured interviews to explore acceptability using the Theoretical Framework of Acceptability.
To test for a medium size effect (d=0.5), at 5% level of significance (2-sided) with power 80%, 64 participants are required in each arm (128 total). Adjusting for 20% attrition requires 154 participants.
Proposed findings The proposed study will demonstrate the effect of a online peer support programme on psychological distress, positive affect, caregiving burden, mastery, personal gain and coping. Data on programme fidelity will enable the investigators to objectively assess acceptability and interpret study results. Data on usability and acceptability will inform future scalability of the online peer support programme outside of the trial both nationally and internationally, and to other family caregiver populations.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Virtual Peer-to-Peer Support
Those participants randomised to the intervention arm will have access to a 12-week virtual peer-to-peer support programme which entails:
1. weekly audio, video, or text private messaging with a peer supporter;
2. synchronous weekly discussion forum attended by peer supporters and family caregiver participants moderated by the research team. These forums will discuss specific topics (e.g. caregiver self-care, the emotional impact of caregiving). Ask the expert forums will be moderated by clinical experts every 6 weeks (meaning all participants will have access to 2 ask the expert sessions);
3. asynchronous discussion forums in which participants can post questions; and
4. access to informational resources.
Virtual peer-to-peer support
See arm description
Control
Those participants randomised to the control arm will receive usual care which comprises self-directed access to the MND Association Visitors programme and MND Association educational resources via their website.
No interventions assigned to this group
Interventions
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Virtual peer-to-peer support
See arm description
Eligibility Criteria
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Inclusion Criteria
2. family/informal caregiver of an individual with MND living at home who is referred for consideration or receiving any of the following i.e., entering King's clinical staging Stage 4A: nutritional support; or Stage 4B: respiratory support \[51\]:
1. assisted ventilation
2. cough assist
3. gastroscopy and enteral feeding
3. able to speak/read English;
4. has access to a computer, tablet, or smartphone and the internet (we have the ability to provide loan 4G enabled tablets if required); and
5. consents to participation
Exclusion Criteria
18 Years
100 Years
ALL
Yes
Sponsors
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MND Association
UNKNOWN
Marie Curie Charity
UNKNOWN
Guy's and St Thomas' NHS Foundation Trust
OTHER
King's College London
OTHER
Responsible Party
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Louise Rose
Professor of Critical Care Nursing
Principal Investigators
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Louise Rose, PhD
Role: PRINCIPAL_INVESTIGATOR
King's College London
Locations
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Bedfordshire Hospitals NHS Foundation Trust
Bedford, , United Kingdom
Airedale NHS Foundation Trust
Bradford, , United Kingdom
University Hospitals Sussex NHS Foundation Trust
Brighton, , United Kingdom
Pilgrims Hospice
Canterbury, , United Kingdom
Coventry Community Specialist Palliative Care Team
Coventry, , United Kingdom
University Hospitals Coventry and Warwickshire NHS Trust
Coventry, , United Kingdom
Ninewells Hospital
Dundee, , United Kingdom
Royal Devon University Healthcare NHS Foundation Trust
Exeter, , United Kingdom
Phyllis Tuckwell Hospice
Farnham, , United Kingdom
Medway Community Healthcare
Gillingham, , United Kingdom
Kingston Hospital NHS Foundation
Kingston upon Thames, , United Kingdom
The Leicestershire & Rutland Organisation for the Relief of Suffering - LOROS
Leicester, , United Kingdom
The Walton Centre NHS Foundation Trust
Liverpool, , United Kingdom
Guy's and St Thomas' NHS Foundation Trust
London, , United Kingdom
Lancashire Teaching Hospitals NHS Foundation Trust
Many Locations, , United Kingdom
Marie Curie Hospice
Many Locations, , United Kingdom
Nottinghamshire Healthcare NHS Foundation Trust
Many Locations, , United Kingdom
Swansea Bay University Health Board
Many Locations, , United Kingdom
Royal Stoke University Hospital/University Hospitals North
Multiple Locations, , United Kingdom
University Hospitals Plymouth NHS trust
Plymouth, , United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, , United Kingdom
Severn Hospice
Shrewsbury, , United Kingdom
St Margaret's Hospice
Taunton, , United Kingdom
Hounslow and Richmond Community Healthcare
Teddington, , United Kingdom
Compton Care
Wolverhampton, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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References
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Rose L, Thaventhiran T, Hobson E, Rogers R, James K, Chu P, Carter B, Faull C, Saha S, Lee JS, Kaltsakas G, McDermott C, Ramsay M. 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. 2023 Feb 20;24(1):119. doi: 10.1186/s13063-023-07124-3.
Other Identifiers
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292922
Identifier Type: -
Identifier Source: org_study_id
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