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

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ClinicalTrials.gov Identifier: NCT04695210
Recruitment Status : Recruiting
First Posted : January 5, 2021
Last Update Posted : August 17, 2022
Sponsor:
Collaborators:
MND Association
Marie Curie Charity
Guy's and St Thomas' NHS Foundation Trust
Information provided by (Responsible Party):
Louise Rose, King's College London

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. 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.


Condition or disease Intervention/treatment Phase
Motor Neuron Disease Amyotrophic Lateral Sclerosis Behavioral: Virtual peer-to-peer support Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 154 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel group single blinded (outcome assessor) randomised controlled trial
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
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
Estimated Study Start Date : August 2022
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2024


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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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)

  3. 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.

  4. 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.


Other Outcome Measures:
  1. 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.

  2. 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



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04695210


Contacts
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Contact: Louise Rose, PhD +44 2078383616 louise.rose@kcl.ac.uk

Locations
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United Kingdom
Bedfordshire Hospitals NHS Recruiting
Bedford, United Kingdom, MK42 9DJ
Contact: Niki Freedman       niki.freedman@ldh.nhs.uk   
Airedale NHS Foundation Trust Recruiting
Bradford, United Kingdom, BD20 6TD
Contact: Linda Wilson       linda.wilson8@nhs.net   
Brighton and Sussex University Hospitals Trust Not yet recruiting
Brighton, United Kingdom, BN2 1DH
Contact: Dee Mullan       dee.mullan@nhs.net   
Pilgrims Hospice Recruiting
Canterbury, United Kingdom
Contact: Charlotte Brigden       Charlotte.Brigden@pilgrimshospices.org   
Ninewells Hospital Recruiting
Dundee, United Kingdom, DD1 9SY
Contact: Tiffany Stewart       Tiffany.Stewart@nhs.scot   
Royal Devon University Healthcare NHS Foundation Trust Recruiting
Exeter, United Kingdom, EX2 5DW
Contact: Aisling Corr       aisling.corr1@nhs.net   
Phyllis Tuckwell Hospice Recruiting
Farnham, United Kingdom, GU9 8BL
Contact: Suzy Williams       Suzy.Williams@pth.org.uk   
Medway Community Healthcare Recruiting
Gillingham, United Kingdom, ME8 0PZ
Contact: Sarah Lavender       sarahlavender@nhs.net   
The Leicestershire & Rutland Organisation for the Relief of Suffering - LOROS Not yet recruiting
Leicester, United Kingdom, LE3 9QE
Contact: Tara Maitland       taramaitland@loros.co.uk   
Guy's and St Thomas' NHS Foundation Trust Recruiting
London, United Kingdom, SE1 9RT
Contact: Rebecca Rogers       peersupport@kcl.ac.uk   
Contact: Thilipan Thaventhiran, PhD       peersupport@kcl.ac.uk   
Nottinghamshire Healthcare NHS Foundation Trust Not yet recruiting
Multiple Locations, United Kingdom
Contact: Melanie Hands       melanie.hands@nottshc.nhs.uk   
Royal Stoke University Hospital/University Hospitals North Recruiting
Multiple Locations, United Kingdom
Contact: Georgia Thomasson       Georgia.Thomasson@uhnm.nhs.uk   
Shrewsbury and Telford Hospital NHS Trust Recruiting
Shrewsbury, United Kingdom, SY3 8XQ
Contact: Jo Stickley       jo.stickley@nhs.net   
St Margaret's Hospice Recruiting
Taunton, United Kingdom, TA1 5HA
Contact: Ali Chedham       ali.chedham@st-margarets-hospice.org.uk   
Compton Care Recruiting
Wolverhampton, United Kingdom
Contact: Anne Piper       annepiper@comptoncare.org.uk   
Sponsors and Collaborators
King's College London
MND Association
Marie Curie Charity
Guy's and St Thomas' NHS Foundation Trust
Investigators
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Principal Investigator: Louise Rose, PhD King's College London
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Responsible Party: Louise Rose, Professor of Critical Care Nursing, King's College London
ClinicalTrials.gov Identifier: NCT04695210    
Other Study ID Numbers: 292922
First Posted: January 5, 2021    Key Record Dates
Last Update Posted: August 17, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Louise Rose, King's College London:
caregiver
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases