Administrative information
Title {1} | 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 Protocol Short title: RCT of virtual peer-to-peer support programme for carers of people living with MND |
Trial registration {2a and 2b}. | ClinicalTrials.gov: NCT04695210. |
Protocol version {3} | Version 1.2; March 11, 2022 |
Funding {4} | Marie Curie Charity. |
Author details {5a} | 1 Florence Nightingale Faculty of Nursing, Midwifery and Palliative Care, James Clerk Maxwell Building, King's College London, London SE1 8WA, United Kingdom 2 Lane Fox Respiratory Service, Guy’s and St Thomas’ NHS Foundation Trust, Westminster Bridge Rd, London, SE17HE, United Kingdom 3 Sheffield Institute for Translational Neuroscience, University of Sheffield, 385a Glossop Rd, Sheffield, S102HQ, United Kingdom 4 Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology & Neuroscience, King's College London, De Crespigny Park, London SE5 8AF, United Kingdom 5LOROS Hospice, Groby Rd, Leicester, LE39QE, United Kingdom 6 King’s College Hospital, Denmark Hill, London, SE59RS, United Kingdom 7 Centre for Human and Applied Physiological Sciences (CHAPS), King's College London, London SE1 8WA, United Kingdom |
Name and contact information for the trial sponsor {5b} | King’s College London Name of Sponsor Representative: Reza Razavi Address: Rm 5.31 James Clerk Maxwell Building, 57 Waterloo Rd, London SE1 8WA, United Kingdom Telephone: 02,078,483,224 Email: reza.razavi@kcl.ac.uk Guy’s & St Thomas’ Foundation NHS Trust Name of Sponsor Representative: Rachel Fay Address: 16th Floor, Tower Wing, Great Maze Pond Telephone: 02,071,887,188 Email: R&D@gstt.nhs.uk |
Role of sponsor {5c} | Role of sponsor includes local Research and Development approval, institutional indemnity insurance for the trial, but does not include funding or trial conduct |
Introduction
Background and rationale {6a}
Objectives {7}
Trial design {8}
Methods: participants, interventions, and outcomes
Study setting {9}
Eligibility criteria {10}
Inclusion | Exclusion |
---|---|
Age ≥ 18 years | Caregiver actively receiving psychiatric/psychologist care identified through self-report prior to consent |
Informal caregiver of a person living with MND at home who is in the later stages of the disease, as evidenced by the need for consideration or receiving any of the following (i.e. entering King’s clinical staging Stage 4A: nutritional support; or Stage 4B: respiratory support): (a) Assisted ventilation (b) Cough assist (c) Gastrostomy and enteral feeding | |
Able to speak/read English | |
Consents to participation |