An ACT Based Application for Young People With Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Acceptability and feasibility of using SweetSpot
研究概览
简要总结
Study Objectives:
This study aims to assess the feasibility and acceptability of an application utilising Acceptance and Commitment Therapy in young people with type 1 diabetes.
Primary Research Questions:
Is an ACT based application feasible and acceptable to young people with type 1 diabetes.
Study Design:
Patients will use the app for four weeks and then be invited to attend an interview discussing the acceptability, usability and feasibility of the app. Clinician's will also be invited to take part in a workshop where they interact with the app and provide feedback.
Consent for will be obtained through the app. Additional consent for the recording of interviews will be obtained in paper format and stored in a secure locked cabinet at Edinburgh University.
Quantitative data will also be collected on well-being, psychological flexibility, and data usage.
Data Collection
Qualitative feedback:
Interviews will be recorded and transcribed using unique identifiers.
Outcome measures and data usage patterns:
Data will be collected on a password protected database which can only be obtained via a password protected and encrypted server from University of Edinburgh.
Data Analysis:
Phase 1:
Framework analysis and interpretive phenomenological analysis will be utilised to create themes from the qualitative feedback.
详细描述
Study Design:
The diabetes teams will select participants who meet inclusion criterion and the team will provide them with information leaflets. The information sheets will include contact details of the research team should any queries arise and contact details of somebody independent from the study. Parents/guardians of volunteers between 13-16 years old will also be able to access the information leaflet so they are aware of the study that their child has volunteered to participate in. The information leaflets will provide information surrounding consent. The information sheets will include a uniform resource locator (URL) where patients who have been selected by their diabetes teams will volunteer to download the app (SweetSpot) from.
Once the individual downloads the application or provided with an Android device by the University, they will be required to provide contact details for themselves, their GP and diabetes teams. This is so GP's can be made aware of the patients participation and so diabetes teams can be informed if the research team have concerns regarding an individual. Additionally, participants can be informed of any relevant developments throughout the study and this can be the forum to disseminate findings from the study.
All identifiable data will be stored electronically on a secure local server and password protected database. Any data removed from this database will be partially identifiable through a unique identifier (UID) which will link the two data sets. Analysis will be conducted on fully anonymised data.
Participants who have volunteered to take part in the study will have approximately four weeks to use the app and will be requested to attended an interview to provide feedback on the feasibility and user-friendliness of the app. As well as obtaining consent through the app, patients participating in this phase will provide consent to participate in the focus group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 22 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •13-22 year olds diagnosed with type 1 diabetes or a clinician working in this field
- •Understand English
- •Android phone
- •If a patient to have been diagnosed for at least 6 months
- •Ability to give consent
排除标准
- •Young people experiencing significant mental health issues. This includes those who are suicidal, experiencing psychosis, or are severely depressed. This will be assessed by the diabetes team which includes psychologists and those potential participants which meet this exclusion criteria will not be asked to participate in the study by the diabetes or research team.
结局指标
主要结局
Acceptability and feasibility of using SweetSpot
时间窗: 4 weeks
Interviews will be conducted
次要结局
- Change in Psychological Flexibility - Diabetes specific (DAAS)(baseline, 4 weeks)
- Change in Psychological Flexibility (AFQ-Y8)(baseline, 4 weeks)
- Change in Glucose Management(baseline, 4 weeks)
- Change in Diabetes Related Distress (PAID-T)(baseline, 4 weeks)
- Well-being(baseline, 4 weeks)
研究者
Estelle Barker
Trainee Clinical Psychologist
University of Edinburgh