Adjustment Post Stroke and Aphasia: Supporting Psychological Wellbeing Through Peer Befriending
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 10
- 主要终点
- General Health Questionnaire-12 (GHQ-12) continuous total score
研究概览
简要总结
Aims: This exploratory trial will:
- Explore the feasibility of a definitive/phase III RCT on clinical and cost-effectiveness of peer-befriending for people with aphasia post-stroke.
- Investigate psychological and social wellbeing outcomes of participants, significant others, and peer befrienders.
- Explore the feasibility of a full economic evaluation of usual care + peer befriending versus usual care control.
Design: Single blind, mixed methods, parallel group phase II RCT comparing usual care + peer-befriending vs. usual care, starting at discharge from hospital. The study will deliver on four work packages: development phase; RCT; qualitative study; economic evaluation. Participants (n=60) will be assessed three times up to 10 months post-randomisation.
Outcome measures: Feasibility: feasibility of recruitment to definitive trial (proportion screened who meet criteria; proportion who consent; rate of consent); participant, significant other, peer befriender views on acceptability of procedures (qualitative study); number of missing/incomplete data on outcome measures; attrition rate at follow-up; potential value of conducting main trial using value of information analysis (economic evaluation); description of usual care; treatment fidelity of peer-befriending. Patient-reported outcomes will include mood, wellbeing, communication and social participation.
Benefits: Peer befriending may help avert some of the serious psychological consequences of stroke, and prevent the need for more complex and costly psychological therapies.
详细描述
Background: Stroke and aphasia can have a profound impact on people's lives. Depression is a common sequel of stroke, with rates remaining high even one year after stroke at 33%. It is associated with worse rehabilitation outcomes, increased carer strain, increased healthcare utilisation, and higher mortality. A recent audit of clinical psychology services for people with mood problems post-stroke across 10 UK stroke services found that the most common outcome of mood assessment was monitoring and advice, with less than half of patients with low mood receiving psychological intervention. There is a pressing need to evaluate systematically interventions that aim to improve psychosocial wellbeing for people with stroke and aphasia.
Aims: SUPERB trial aims to evaluate the feasibility of a phase III trial on the clinical and cost-effectiveness of a stepped care model level 1 intervention, peer befriending, for people with aphasia. Specifically it will:
- Explore the feasibility of a definitive phase III randomised control trial (RCT) based on a) feasibility of recruitment and retention to the trial, b) acceptability of research procedures and outcome measures, c) acceptability of usual care + peer befriending vs. usual care control to participants, their significant others and peer support workers, d) documentation of usual care, e) treatment fidelity of peer befriending.
- Explore psychological and social well-being outcomes as outcomes in a definitive trial for a) people with aphasia receiving usual care + peer befriending versus usual care control, b) their significant others, and c) peer befrienders.
- Explore the feasibility of a full economic evaluation of usual care + peer befriending versus usual care control in a phase III RCT.
Intervention to be tested: The intervention group will receive peer befriending from stroke survivors with long-term aphasia who will be trained as peer befrienders. They will visit participants who have had a stroke more recently 6 times over a period of 3 months. An further 2 visits within the next 6 months will also be offered for a gradual transition to the end of the peer befriending. The schedule and nature of visits will be agreed between the pair at their first meeting. This meeting will also identify possible goals for the intervention e.g. to offer conversation, help with problem solving and social activities.
Methods: The overall study will last 3½ years and comprise a development phase (year 1) and a phase II RCT (years 2-3). The development phase will inform the intervention manual, the choice of outcome measures, fidelity practices and topic guides for participant interviews. This phase will be informed through a series of six workshops attended by six people with aphasia with experience of peer befriending. This will be followed by a pilot of the intervention, fidelity checking and all associated processes with 8 participants comparing usual care (n=4) with usual care + peer befriending (n=4).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Participants with aphasia:
- •Fluent premorbid users of English (confirmed by relative or self report);
- •Presence of aphasia due to stroke; and
- •Low levels of emotional distress (score of ≤2 on Depression Intensity Scale Circles). The latter will ensure that they do not require immediate level 2 or 3 psychological input. People who score 2 (which is also the median on DISCS) and who the MDT deems do not need stepping up or stepping up is not available, will still be eligible to take part.
- •Significant Others: each participant with aphasia will nominate one significant other, who is their closest confidant and who is over 18 years of age. If participants live alone their significant other should be someone that they see at least once a week.
- •Peer befrienders: will be people with mild-moderate aphasia (score score a minimum 5/10 for auditory comprehension and 5/10 for verbal expression in the Frenchay Aphasia Screening Test) who are over 18 years of age, are at least one year post-stroke
排除标准
- •Participants will be excluded if they have:
- •Other diagnoses affecting cognition or mental health (based on medical records for participants with aphasia and self-report for significant others and peer befrienders, as well as the GHQ-12 as a depression screen for peer befrienders: will be excluded if they score 3 or more);
- •Severe uncorrected visual or hearing problems (based on medical records for participants with aphasia and self-report for significant others and peer befrienders);
- •Severe or potentially terminal co-morbidities, on grounds of frailty (based on medical records for participants with aphasia and self-report for significant others and peer befrienders).
- •Participants with aphasia will also be excluded if they are:
- •Discharged to a geographical location outside the borough of the recruiting hospital.
结局指标
主要结局
General Health Questionnaire-12 (GHQ-12) continuous total score
时间窗: 10 months post randomisation
For participants with aphasia.
Depression Intensity Scale Circles (DISCS) continuous total score
时间窗: 10 months post randomisation
The DISCS will be treated as the primary outcome measure only if there is ≥10% missing data in the GHQ-12 due to severity of aphasia, otherwise it will be a secondary outcome measure.
次要结局
- Communicative Participation Item Bank (CPIB) continuous total score(10 months post randomisation)
- Short Warwick Edinburgh Mental Well-being Scale (SWEMWBS) continuous total score.(10 months post randomisation)
- Community Integration Questionnaire (CIQ) continuous total score(~ 6 months)
- Proportion with high emotional distress vs low emotional distress as measured using the GHQ-12 (high distress = score of 3 or more, low distress = score of 0-2)(10 months post randomisation)
- General Health Questionnaire-28 (GHQ-28) continuous total score. The GHQ-28 also provides four subscale scores (somatic symptoms, anxiety/insomnia, severe depression, and social dysfunction), which will be looked at descriptively.(10 months post randomisation)
- Bakas Caregiving Outcome Scale (BCOS) continuous total score(10 months post randomisation)
- Warwick Edinburgh Mental Well-being Scale (WEMWBS) continuous total score(~ 6 months)