A Feasibility Randomised-Controlled Trial of Two Online Psychological Interventions for Stroke Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Support to complete questionnaires
研究概览
简要总结
Many people have difficulties organising their behaviour and problem-solving (also known as executive function difficulties) after stroke. This can have serious, wide-ranging consequences for wellbeing and ability to regain independence. Currently, access to psychological interventions after stroke varies and there is not enough evidence to recommend a specific intervention for executive function difficulties after stroke. A short intervention was designed to help with executive function difficulties by making it easier to set goals and achieve them after stroke. The intervention is designed for online delivery to make it accessible to as many stroke survivors as possible. The present trial aims to investigate the acceptability and feasibility of a single blinded randomized controlled trial of this online executive function intervention (active intervention) compared to an online stroke psychoeducation intervention (control intervention).
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
- Triple (Participant, Care Provider, 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
- •Diagnosis of stroke
- •≥ 18 years of age
- •Capacitous consent to participate
- •Access to a computer / tablet, the internet, and an email address
排除标准
- •Another significant mental or physical health condition
- •Current involvement in another research trial
- •Severe depression (over 20 on PHQ-9)
- •Not able to read or understand English
- •Visual, auditory or motor difficulties of a severity that limit the ability to attend to the content of the interventions, read the Participant Information Sheet or complete the consent form and outcome measures
- •Not registered with a GP or unwilling to provide GP information (for reporting suicidal ideation concerns
结局指标
主要结局
Support to complete questionnaires
时间窗: Through study completion, an average of 15 months.
Number of participants requiring support to complete questionnaires and time taken per participant
Recruitment Rate
时间窗: Through study completion, approximately 15 months.
Rate of participants recruited into the trial amongst all participants screened
Follow-up rate
时间窗: Through study completion, an average of 15 months.
Rate of participants included at 1-month follow-up
Time required to collect and analyze data
时间窗: Through study completion, an average of 15 months.
Time required for data collection per participant and final analysis
Questionnaire reminders
时间窗: Through study completion, an average of 15 months.
Number of questionnaire reminders sent and time taken per participant
Attrition Rate
时间窗: Through study completion, an average of 15 months.
Rate of participants and data lost
Exclusion Rate
时间窗: Through study completion, an average of 15 months.
Rate of participants excluded from participating amongst all participants screened
次要结局
- The Short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWBS, Tennant et al., 2007)(Baseline, post-intervention and at 1-month follow-up.)
- Revised Dysexecutive Questionnaire (DEX-R; Simblett, Ring & Bateman, 2016)(Baseline, post-intervention and at 1-month follow-up.)
- Feedback survey(Post-intervention.)
- The Patient Health Questionnaire-9 (PHQ-9)(Screening)
- The ICECAP-A (ICEpop CAPability measure for Adults; Al-Janabi, Flynn & Coast, 2012)(Baseline, post-intervention and at 1-month follow-up.)
- The stroke self-efficacy scale (SSES; Jones et al., 2008)(Baseline, post-intervention and at 1-month follow-up.)
研究者
Catherine Ford
Clinical Associate Professor in Clinical Psychology
University of East Anglia