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

April 26, 2023 updated by: Louise Rose, King's College London

A Virtual Peer-to-peer Support Programme for Family Caregivers of Individuals With Motor Neurone Disease at Risk of Becoming or Currently Technology-dependent: Randomised Controlled Trial

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. 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

154

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Kingdom
      • Bedford, United Kingdom, MK42 9DJ
      • Bradford, United Kingdom, BD20 6TD
      • Brighton, United Kingdom, BN2 1DH
      • Canterbury, United Kingdom
      • Coventry, United Kingdom, CV2 2DX
        • Recruiting
        • University Hospitals Coventry and Warwickshire NHS Trust
        • Contact:
      • Coventry, United Kingdom, CV1 4NZ
      • Dundee, United Kingdom, DD1 9SY
      • Exeter, United Kingdom, EX2 5DW
        • Recruiting
        • Royal Devon University Healthcare NHS Foundation Trust
        • Contact:
      • Farnham, United Kingdom, GU9 8BL
      • Gillingham, United Kingdom, ME8 0PZ
      • Kingston upon Thames, United Kingdom, KT2 7QB
      • Leicester, United Kingdom, LE3 9QE
        • Recruiting
        • The Leicestershire & Rutland Organisation for the Relief of Suffering - LOROS
        • Contact:
      • Liverpool, United Kingdom, L9 7LJ
      • London, United Kingdom, SE1 9RT
      • Multiple Locations, United Kingdom
        • Recruiting
        • Royal Stoke University Hospital/University Hospitals North
        • Contact:
      • Multiple Locations, United Kingdom
      • Multiple Locations, United Kingdom
      • Multiple Locations, United Kingdom
      • Multiple Locations, United Kingdom
      • Plymouth, United Kingdom, PL6 8DH
      • Sheffield, United Kingdom, S10 2JF
      • Shrewsbury, United Kingdom, SY3 8HS
      • Taunton, United Kingdom, TA1 5HA
      • Teddington, United Kingdom, TW11 8HU
      • Wolverhampton, United Kingdom

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. age ≥ 18 years;

  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:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: Virtual peer-to-peer support
See arm description
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital Anxiety and Depression Score (HADS)
Time Frame: 6 weeks & 12 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Positive and Negative Affect Schedule
Time Frame: 12 weeks
10-item Positive Affect Scale of the Positive and Negative Affect Schedule from baseline to programme completion. Scores range from 10 to 50; higher scores indicate more psychological well-being.
12 weeks
Zarit Burden Interview (ZBI)
Time Frame: 6 weeks & 12 weeks
Change in ZBI score from baseline to programme completion. The sum of scores ranges between 0 to 88. Higher scores indicate greater burden. Caregivers can be categorised as 'highly burdened' (score of ≥ 24) and low burdened groups (score <24)
6 weeks & 12 weeks
Pearlin Mastery Scale
Time Frame: 12 weeks
Change in Pearlin Mastery Scale from baseline to programme completion. The Pearlin Mastery Scale is a 7 item scale with scores from 7 to 28. Higher scores indicate a greater sense of control over life.
12 weeks
Brief-COPE (note COPE is not an abbreviation)
Time Frame: 12 weeks
Change in Brief COPE from baseline to programme completion. 14 scales with 2 items (28 items in total. Scores on each scale range from 2 (minimum) to 8 (maximum). Higher scores indicate increased utilisation of that specific coping strategy.
12 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Usability
Time Frame: At 12 weeks following programme completion
For those participants in the intervention arm, on programme completion we will also ask them to rate the usability of the virtual peer-to-peer support programme on a 9-point Likert scale ranging from difficult to easy.
At 12 weeks following programme completion
Acceptability
Time Frame: After 12 weeks following programme completion
Semi-structured qualitative interviews exploring perceived acceptability of the virtual peer-to-peer support programme following programme completion
After 12 weeks following programme completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King's College London

Collaborators

Guy's and St Thomas' NHS Foundation Trust
MND Association
Marie Curie Charity

Investigators

  • Principal Investigator: Louise Rose, PhD, King's College London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 15, 2022

Primary Completion (Anticipated)

December 31, 2024

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

December 19, 2020

First Submitted That Met QC Criteria

January 4, 2021

First Posted (Actual)

January 5, 2021

Study Record Updates

Last Update Posted (Actual)

April 27, 2023

Last Update Submitted That Met QC Criteria

April 26, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 292922

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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