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| Name | Class |
|---|---|
| MND Association | UNKNOWN |
| Marie Curie Charity | UNKNOWN |
| Guy's and St Thomas' NHS Foundation Trust | OTHER |
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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:
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
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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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:
|
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual peer-to-peer support | Behavioral | See arm description |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 weeks |
| Zarit Burden Interview (ZBI) |
| Measure | Description | Time Frame |
|---|---|---|
| Usability | 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 |
Inclusion Criteria:
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
Exclusion Criteria:
1. Actively receiving psychiatric/psychologist care identified through self-report.
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| Name | Affiliation | Role |
|---|---|---|
| Louise Rose, PhD | King's College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bedfordshire Hospitals NHS Foundation Trust | Bedford | MK42 9DJ | United Kingdom | |||
| Airedale NHS Foundation Trust |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36805758 | Derived | 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. |
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Parallel group single blinded (outcome assessor) randomised controlled trial
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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 | 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) | 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 |
Semi-structured qualitative interviews exploring perceived acceptability of the virtual peer-to-peer support programme following programme completion |
| After 12 weeks following programme completion |
| Bradford |
| BD20 6TD |
| United Kingdom |
| University Hospitals Sussex NHS Foundation Trust | Brighton | BN2 1DH | United Kingdom |
| Pilgrims Hospice | Canterbury | United Kingdom |
| Coventry Community Specialist Palliative Care Team | Coventry | CV1 4NZ | United Kingdom |
| University Hospitals Coventry and Warwickshire NHS Trust | Coventry | CV2 2DX | United Kingdom |
| Ninewells Hospital | Dundee | DD1 9SY | United Kingdom |
| Royal Devon University Healthcare NHS Foundation Trust | Exeter | EX2 5DW | United Kingdom |
| Phyllis Tuckwell Hospice | Farnham | GU9 8BL | United Kingdom |
| Medway Community Healthcare | Gillingham | ME8 0PZ | United Kingdom |
| Kingston Hospital NHS Foundation | Kingston upon Thames | KT2 7QB | United Kingdom |
| The Leicestershire & Rutland Organisation for the Relief of Suffering - LOROS | Leicester | LE3 9QE | United Kingdom |
| The Walton Centre NHS Foundation Trust | Liverpool | L9 7LJ | United Kingdom |
| Guy's and St Thomas' NHS Foundation Trust | London | SE1 9RT | 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 | PL6 8DH | United Kingdom |
| Sheffield Teaching Hospitals NHS Foundation Trust | Sheffield | S10 2JF | United Kingdom |
| Severn Hospice | Shrewsbury | SY3 8HS | United Kingdom |
| St Margaret's Hospice | Taunton | TA1 5HA | United Kingdom |
| Hounslow and Richmond Community Healthcare | Teddington | TW11 8HU | United Kingdom |
| Compton Care | Wolverhampton | United Kingdom |
| ID | Term |
|---|---|
| D016472 | Motor Neuron Disease |
| D000690 | Amyotrophic Lateral Sclerosis |
| ID | Term |
|---|---|
| D019636 | Neurodegenerative Diseases |
| D009422 | Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D057177 | TDP-43 Proteinopathies |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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