Virtual Peer-to-peer Support Programme for Carers of MND

NCT04695210 | Recruiting DMC

• 1 other identifier: 292922
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 25

Brief Summary

Background/scope There is growing recognition that family caregiving is a serious public health issue requiring supportive interventions. Family caregivers play an essential role in sustaining a stable environment enabling individuals with motor neurone disease (MND) that are technology dependent to live at home. The family caregivers can experi¬ence exceptional burden and significant decline in psychological wellbeing due to MND's rapid and pro¬gressive nature with profoundly debilitating effects and intensive support needs. Dependence on assistive technology adds an additional level of complexity to family caregiving due to the need to learn how to operate and troubleshoot medical devices, train other caregivers, and negotiate appointments with new specialties within the healthcare system. 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. 1.What is the effect on positive affect, caregiver burden, caregiving mastery, caregiving personal gain, and coping?
2. 2.How do participants use the programme (fidelity and reach)?
3. 3.What is the perceived usability and acceptability?
4. 4.assisted ventilation
5. 5.cough assist
6. 6.gastroscopy and enteral feeding
7. 7.audio, video, or text private messaging;
8. 8.synchronous weekly chat;
9. 9.asynchronous discussion forum; and
10. 10.informational resources.

Conditions

Motor Neuron Disease; Amyotrophic Lateral Sclerosis

Keywords

caregiver

Outcome Measures

Primary Outcomes (1)

• Hospital Anxiety and Depression Score (HADS)

  Change in Hospital Anxiety and Depression Score from baseline to programme completion. The Hospital Anxiety and Depression Score Overall score ranges from 0 \[best\] to 21 \[worst\] with cutoff points of \>7 (possible) and \>10 (probable) indicating cases of anxiety or depression.

  6 weeks & 12 weeks

Secondary Outcomes (4)

• Positive and Negative Affect Schedule

  12 weeks

• Zarit Burden Interview (ZBI)

  6 weeks & 12 weeks

• Pearlin Mastery Scale

  12 weeks

• Brief-COPE (note COPE is not an abbreviation)

  12 weeks

Other Outcomes (2)

• Usability

  At 12 weeks following programme completion

• Acceptability

  After 12 weeks following programme completion

Study Arms (2)

Virtual Peer-to-Peer Support

EXPERIMENTAL

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.

Behavioral: Virtual peer-to-peer support

Control

NO INTERVENTION

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.

Interventions

Virtual peer-to-peer support BEHAVIORAL

See arm description

Virtual Peer-to-Peer Support

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age ≥ 18 years;
• 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 \[51\]:
• assisted ventilation
• cough assist
• gastroscopy and enteral feeding
• able to speak/read English;
• has access to a computer, tablet, or smartphone and the internet (we have the ability to provide loan 4G enabled tablets if required); and
• consents to participation

You may not qualify if:

• \. Actively receiving psychiatric/psychologist care identified through self-report.

Sponsors & Collaborators

• King's College London: lead
• MND Association: collaborator
• Marie Curie Charity: collaborator
• Guy's and St Thomas' NHS Foundation Trust: collaborator

Study Sites (25)

Bedfordshire Hospitals NHS Foundation Trust

Bedford, MK42 9DJ, United Kingdom

RECRUITING

Airedale NHS Foundation Trust

Bradford, BD20 6TD, United Kingdom

RECRUITING

University Hospitals Sussex NHS Foundation Trust

Brighton, BN2 1DH, United Kingdom

RECRUITING

Pilgrims Hospice

Canterbury, United Kingdom

RECRUITING

Coventry Community Specialist Palliative Care Team

Coventry, CV1 4NZ, United Kingdom

RECRUITING

University Hospitals Coventry and Warwickshire NHS Trust

Coventry, CV2 2DX, United Kingdom

RECRUITING

Ninewells Hospital

Dundee, DD1 9SY, United Kingdom

RECRUITING

Royal Devon University Healthcare NHS Foundation Trust

Exeter, EX2 5DW, United Kingdom

RECRUITING

Phyllis Tuckwell Hospice

Farnham, GU9 8BL, United Kingdom

RECRUITING

Medway Community Healthcare

Gillingham, ME8 0PZ, United Kingdom

RECRUITING

Kingston Hospital NHS Foundation

Kingston upon Thames, KT2 7QB, United Kingdom

RECRUITING

The Leicestershire & Rutland Organisation for the Relief of Suffering - LOROS

Leicester, LE3 9QE, United Kingdom

RECRUITING

The Walton Centre NHS Foundation Trust

Liverpool, L9 7LJ, United Kingdom

RECRUITING

Guy's and St Thomas' NHS Foundation Trust

London, SE1 9RT, United Kingdom

RECRUITING

Lancashire Teaching Hospitals NHS Foundation Trust

Many Locations, United Kingdom

RECRUITING

Marie Curie Hospice

Many Locations, United Kingdom

RECRUITING

Nottinghamshire Healthcare NHS Foundation Trust

Many Locations, United Kingdom

RECRUITING

Swansea Bay University Health Board

Many Locations, United Kingdom

RECRUITING

Royal Stoke University Hospital/University Hospitals North

Multiple Locations, United Kingdom

RECRUITING

University Hospitals Plymouth NHS trust

Plymouth, PL6 8DH, United Kingdom

RECRUITING

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, S10 2JF, United Kingdom

RECRUITING

Severn Hospice

Shrewsbury, SY3 8HS, United Kingdom

RECRUITING

St Margaret's Hospice

Taunton, TA1 5HA, United Kingdom

RECRUITING

Hounslow and Richmond Community Healthcare

Teddington, TW11 8HU, United Kingdom

RECRUITING

Compton Care

Wolverhampton, United Kingdom

RECRUITING

Related Publications (1)

• 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.

  PMID: 36805758 DERIVED

MeSH Terms

Conditions

Motor Neuron Disease; Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Neurodegenerative Diseases; Nervous System Diseases; Neuromuscular Diseases; Spinal Cord Diseases; Central Nervous System Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Louise Rose, PhD

  King's College London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Louise Rose, PhD

CONTACT

+44 2078383616; louise.rose@kcl.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Critical Care Nursing

Model Details: Parallel group single blinded (outcome assessor) randomised controlled trial

Study Record Dates

• First Submitted: December 19, 2020
• First Posted: January 5, 2021
• Study Start: August 15, 2022
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: October 22, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (25)