Providing Emotional Support Around the Point of Multiple Sclerosis Diagnosis (PrEliMS): A Feasibility Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Documentation of usual care
研究概览
简要总结
The PrEliMS study is a mixed-methods feasibility randomised controlled trial of a point of diagnosis intervention programme which aims to provide emotional support for newly diagnosed people with Multiple Sclerosis (MS). This feasibility study will enable us to plan for a definitive trial to evaluate the clinical and cost-effectiveness of this point of diagnosis intervention programme. The aim is to assess the feasibility of the trial procedures and intervention, and to evaluate the key feasibility parameters before proceeding to a definitive trial. Participants (N=60) will be randomised into three groups: (1) usual care; (2) usual care + Support 1 (MS Nurse Support); (2) usual care + Support 2 (MS Nurse Support plus Peer Support).
详细描述
Potential participants will be people who have been recently diagnosed with MS (or currently going through diagnosis process), and who are aged 18 years or over, recruited through MS clinics. Participants, after consent, will complete baseline measures before being randomised into to one of three groups: (1) usual care; (2) usual care + Support 1 (MS Nurse Support); (2) usual care + Support 2 (MS Nurse Support plus Peer Support). Group 1 (20 patients) will not receive any intervention. Group 2 (20 patients) will receive Support 1 which will include one face-to-face support session delivered by an MS Nurse. Group 3 (20 patients) will receive Support 2 which includes MS Nurse Support (i.e., Support 1) plus Peer Support. Peer Support will include a minimum of two peer support session delivered by Peer Support Workers (i.e. patients with lived experiences). All groups will receive usual care. The outcome measures will be collected at 3 and 6 months after randomisation by all participants. Feedback interviews with up to 21 participants (7 from each group) and up to 10 service providers (5 MS Nurses who delivered the MS Nurse Support and 5 Peer Support Workers who delivered the Peer Support) will be conducted to assess what parts of the intervention were helpful or unhelpful, the acceptability of randomisation and trial procedures, and the appropriateness of the measures used.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients will be eligible to join the trial if they:
- •are 18 years or over
- •have recently received a diagnosis of MS (any type of MS) or currently going through MS diagnosis process)
- •can communicate in English
- •able and willing to give consent
- •not receiving psychological intervention
排除标准
- •Patients will be excluded if they:
- •have a severe co-morbid psychiatric condition (e.g. dementia), as reported by patients or their carers or confirmed by the clinical team making the initial approach
- •are currently receiving psychological interventions or received this within the last three months (we will not exclude those on medication for their mood problems but will record this information).
- •do not have mental capacity to consent to take part in the trial
- •are unable to communicate in English
结局指标
主要结局
Documentation of usual care
时间窗: Daily throughout data collection
Data obtained through service use questionnaire and feedback interviews.
Feasibility of collecting data for an economic evaluation using a bespoke service use questionnaire
时间窗: Daily throughout data collection
Number of missing or clearly invalid service use questionnaire data, completion rates, exploration of possible ceiling effects, feedback interview (qualitative) data.
Credibility of interventions
时间窗: Daily throughout data collection
Assessed through qualitative feedback interview data (i.e., questions about the content of the intervention, changes experienced).
Feasibility of delivering Support 2 intervention
时间窗: Daily throughout intervention delivery
Number of missed and rescheduled sessions, length of sessions (minutes), operational issues in delivering intervention through feedback interview data.
Estimating sample size needed for a Phase III RCT
时间窗: Daily throughout data collection
Sample size calculated through effect sizes from ANOVAs, standard deviations and attrition rates.
Feasibility of self-report data collection
时间窗: Daily throughout data collection
Number of missing online and postal data
Feasibility of delivering Support 1 intervention
时间窗: Daily throughout intervention delivery
Number of missed and rescheduled sessions, length of sessions (minutes), operational issues in delivering intervention through feedback interview data.
Acceptability of trial procedures
时间窗: Daily throughout data collection
Assessed through feedback interview (qualitative) data from participants and service providers on the trial procedures.
Feasibility of recruitment
时间窗: Daily throughout data collection
Number of those eligible who expressed interest/discussed with researcher, number of consenting/randomised patients, reasons for non-participation, retention rates, feedback interview (qualitative) data.
Feasibility of randomisation protocol
时间窗: Daily throughout data collection
Assessed through feedback interview (qualitative) data on randomisation protocol and willingness and acceptance of patients to be randomised.
Feasibility of trial procedures
时间窗: Daily throughout data collection
\[Note: As feasibility studies are used to estimate important parameters to inform the design of a full trial (NIHR, 2018), we outline the key outcomes related to feasibility. These are described below. Please see Outcome 1-15.\] Feasibility of trial procedures will be assessed through feedback interview (qualitative) data from participants and service providers (i.e., questions about the research process/procedures, and suggested changes to the study).
Appropriateness of measures
时间窗: Daily throughout data collection
Completion rates of outcome measures, number of missing online and postal data, estimates of time (minutes) taken to complete measures (from online/phone data or feedback interview data).
Feasibility of audio recording support sessions
时间窗: Daily throughout data collection
Number of participants consenting to audio recording of sessions and feedback interview data
Acceptability of interventions (Support 1 and Support 2)
时间窗: Daily throughout intervention delivery
Drop-out rates (and reasons for withdrawal), number of Support 1 and Support 2 sessions completed, feedback interview data.
Fidelity of intervention
时间窗: Daily throughout intervention delivery
Fidelity rating on audio data from a sample of support sessions against criteria for PrEliMS model consistency.
次要结局
未报告次要终点