Motor Neuron DiseaseNCT04695210
Virtual Peer-to-peer Support Programme for Carers of MND
A study testing Virtual peer-to-peer support in people with Motor Neuron Disease and Amyotrophic Lateral Sclerosis, run by King's College London at 25 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Motor Neuron Disease, Amyotrophic Lateral Sclerosis
- What is being tested?
- Virtual peer-to-peer support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 149 participants
- Where
- 25 sitesUnited Kingdom
- Study dates
- 7 Jun 2022to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 1. Actively receiving psychiatric/psychologist care identified through self-report.
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
United Kingdom25 sites
Bedfordshire Hospitals NHS Foundation Trust
Bedford, MK42 9DJ
Airedale NHS Foundation Trust
Bradford, BD20 6TD
University Hospitals Sussex NHS Foundation Trust
Brighton, BN2 1DH
Pilgrims Hospice
Canterbury
Coventry Community Specialist Palliative Care Team
Coventry, CV1 4NZ
University Hospitals Coventry and Warwickshire NHS Trust
Coventry, CV2 2DX
Ninewells Hospital
Dundee, DD1 9SY
Royal Devon University Healthcare NHS Foundation Trust
Exeter, EX2 5DW
Phyllis Tuckwell Hospice
Farnham, GU9 8BL
Medway Community Healthcare
Gillingham, ME8 0PZ
Kingston Hospital NHS Foundation
Kingston upon Thames, KT2 7QB
The Leicestershire & Rutland Organisation for the Relief of Suffering - LOROS
Leicester, LE3 9QE
The Walton Centre NHS Foundation Trust
Liverpool, L9 7LJ
Guy's and St Thomas' NHS Foundation Trust
London, SE1 9RT
Lancashire Teaching Hospitals NHS Foundation Trust
Many Locations
Marie Curie Hospice
Many Locations
Nottinghamshire Healthcare NHS Foundation Trust
Many Locations
Swansea Bay University Health Board
Many Locations
Royal Stoke University Hospital/University Hospitals North
Multiple Locations
University Hospitals Plymouth NHS trust
Plymouth, PL6 8DH
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, S10 2JF
Severn Hospice
Shrewsbury, SY3 8HS
St Margaret's Hospice
Taunton, TA1 5HA
Hounslow and Richmond Community Healthcare
Teddington, TW11 8HU
Compton Care
Wolverhampton
About this study
Official title: 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.
Read more
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:
- What is the effect on positive affect, caregiver burden, caregiving mastery, caregiving personal gain, and coping?
- How do participants use the programme (fidelity and reach)?
- 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
- assisted ventilation
- cough assist
- 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:
- audio, video, or text private messaging;
- synchronous weekly chat;
- asynchronous discussion forum; and
- 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.
- Being tested
- Virtual peer-to-peer support
- Keywords
- caregiver
- Medical subject headings
- Motor Neuron Disease, Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual peer-to-peer supportBehavioural
See arm description
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks & 12 weeks
Secondary outcomes (4)
Positive and Negative Affect Schedule
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.
Measured: 12 weeks
Zarit Burden Interview (ZBI)
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)
Measured: 6 weeks & 12 weeks
Pearlin Mastery Scale
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.
Measured: 12 weeks
Brief-COPE (note COPE is not an abbreviation)
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start7 Jun 2022
- Primary completion31 May 2025
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Motor Neuron DiseaseStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel group single blinded (outcome assessor) randomised controlled trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- MND Association, Marie Curie Charity, Guy's and St Thomas' NHS Foundation Trust
- Responsible party
- Principal investigator, Louise Rose, King's College London
- Investigators
- Louise Rose, PhD, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04695210
- Sponsor's protocol ID
- 292922
- Status last verified
- Oct 2024
- First submitted
- 19 Dec 2020
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36805758
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04695210
- Acronym / sponsor ID
- 292922
- Keywords
- caregiver
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- MND Association, Marie Curie Charity, Guy's and St Thomas' NHS Foundation Trust
- Study start
- 7 Jun 2022 (actual)
- Primary completion
- 31 May 2025 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 5 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- What is the effect on positive affect, caregiver burden, caregiving mastery, caregiving personal gain, and coping?
- How do participants use the programme (fidelity and reach)?
- 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
- assisted ventilation
- cough assist
- 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:
- audio, video, or text private messaging;
- synchronous weekly chat;
- asynchronous discussion forum; and
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel group single blinded (outcome assessor) randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Virtual Peer-to-Peer Support | Experimental | Behavioral: Virtual peer-to-peer supportThose 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. |
| 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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]:
- 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
Key exclusion criteria (1 listed)
- 1. Actively receiving psychiatric/psychologist care identified through self-report.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual peer-to-peer supportSee arm description | Behavioural | Virtual Peer-to-Peer Support |
Primary outcome
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.
4 secondary outcomes
Positive and Negative Affect Schedule
Time frame: 12 weeks
Zarit Burden Interview (ZBI)
Time frame: 6 weeks & 12 weeks
Pearlin Mastery Scale
Time frame: 12 weeks
Brief-COPE (note COPE is not an abbreviation)
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Derived from this study: PubMed 36805758Rose 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Louise Rose, PhD principal investigator
King's College London
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual peer-to-peer support in people with Motor Neuron Disease and Amyotrophic Lateral Sclerosis, run by King's College London at 25 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital Anxiety and Depression Score (HADS) (time frame: 6 weeks & 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04695210, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.