Authors
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Edwards, Laura -More
Category
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Primary study
Registry of Trials»ISRCTN registry
Year
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2022
INTERVENTION: Randomization: simple randomization via an online system Intervention: 5 participants will attend a brief training and education session to become familiarised with the VR headset and its use (facilitated remotely if required). They will be provided with their own headset which is pre‐loaded with an 8‐week programme, consisting of 56 modules designed to support people with chronic pain with 56 different VR experiences to educate, relax, distract and empower them (EaseVRx). AppliedVR’s headset has been specifically designed to be user‐friendly, lightweight and to be used by people with restricted mobility, which is particularly appealing for our patient population. On average, the VR experiences last for 7 minutes (range 2‐15 minutes). The 8‐week programme is designed to be worked through sequentially, with weekly themes including “The Mind and Pain Relief” (week 2); “Relaxation” (week 4) and “Journey to Wellness” (week 8). It is designed for one session to be delivered each day, and once one session has completed, the next session automatically appears for the user. On‐demand content is also available if the user wishes to have extra sessions. It is anticipated that the different experiences may be attractive to different individuals and will explore this in our qualitative work. Once participants (with carers if required) are confident and comfortable using the headset, they will be asked to use it at home on a daily basis (no upper limit on use) and to record when they used it. If they choose to use extra “on‐demand” experiences, the researchers will ask them to record which experience they chose each time. After 8 weeks, the headset will be returned to the investigators. CONDITION: Multiple sclerosis ; Nervous System Diseases ; Multiple sclerosis PRIMARY OUTCOME: ; Feasibility:; 1. Recruitment assessed by meeting the recruitment target of 10 participants at 10 weeks from study recruitment opening; 2. Retention: rates of drop‐out assessed by simple counting at 4, 8 and 12 weeks from randomisation.; 3. Study delivery: provision of sufficient reliably‐working headsets which are easy for PwMS to don, doff and use, based on participant/carer report at each timepoint and by participant‐generated feedback in‐between timepoints as required.; 4. Reliability of use: assessed using the frequency of use recorded by the VR headset and participant reports, and compliance assessed with participant interviews at 4, 8 and 12 weeks; ; The feasibility of conducting an incremental cost‐effectiveness analysis alongside a full RCT of the home‐based VR intervention over and above the control, assessed by collecting basic health service utilisation data from patients with respect to contacts with primary and secondary health care and social services at 4, 8 and 12 weeks.; INCLUSION CRITERIA: 1. Progressive multiple sclerosis (PMS) (primary or secondary) (OR friend/relative/carer of a person with PMS) 2. Aged 18 years or over 3. Capable of giving informed consent 4. Participant able to don and doff headset and/or indicate wish for headset to be donned and doffed 5. At least one hidden symptom of MS (HSMS) SECONDARY OUTCOME: ; MS‐related outcomes:; Participants will complete questionnaires/intervention details as at baseline at the end of weeks 3 and 6 (see below for details of questionnaires). There will be a further set of follow‐up questionnaires 1 month after the intervention period ends. Questionnaires can be completed by the participant, by the participant and carer together, or by the participant (with or without carer) with the investigator via telephone, online or in person to try to minimise drop‐out and non‐completion due to questionnaire burden.; 1. Pain measured using the Wong‐Baker FACES Pain Rating Scale; 2. Quality of life measured using the Leeds MS QoL; 3. Fatigue measured using the Fatigue Severity Scale (FSS); 4. Well‐being measured using Coop/Wonca?charts; 5. Sleep measured using the Athens Insomnia Scale; 6. Overall MS symptoms measured using the Multiple Sclerosis Impact Scale (MSIS‐29); 7. Health status measured using EQ‐5D‐5L for informing health economics analysis; ; Qualitative outcomes:; Participants in each arm will be invited to take part in a more in‐depth user experience study at the beginning of the study. This will include real‐time user observation of the VR/relaxation programme with opportunistic questioning and in‐depth qualitative interviews to explore the experience of using the interventions, barriers or facilitators to use, and any changes that they would recommend for future work.; If participants have partners/carers/family members who are willing to participate, the researchers will ask about their experiences of the study and intervention. There are many facets of wellbeing and QoL in MS that will not map onto the selected questionnaires. The researchers will therefore examine issues identified and described by our participants as being important to their experiences. They will seek participant feedback regarding outcome measures.; ; Health economics outcomes:; The feasibility of conducting an incremental cost‐effectiveness analysis alongside a full RCT of the home‐based VR intervention over and above the control, assessed by collecting basic health service utilisation data from patients with respect to contacts with primary and secondary health care and social services;
Epistemonikos ID: dae44056c9e1ca70055441236faaba9ca4afec47
First added on: Aug 25, 2024