KEEP- A Randomised Feasibility Study of a Co-designed Physical Health Education Intervention to Improve Knowledge, Exercise Efficacy and Participation for Newly Diagnosed People With Parkinson's.
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Parkinson Disease
- 发起方
- University of Cambridge
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Acceptability assessment 3: Drop out rate
- 状态
- 进行中（未招募）
- 最后更新
- 3年前
概览
简要总结
Parkinson's Disease (PD) is a progressive neurological condition that affects movement, balance and cognition, resulting in loss of independence and compromised quality of life over the course of the condition. Research suggests that those detrimental outcomes can be reduced through physical activity (PA) and exercise, especially when those are started early. Educating people with Parkinson's (PwP) on the role of PA and exercise in PD progression can boost PA engagement by increasing enablers such as exercise self-efficacy and removing barriers such as misinformation about exercise and exercise outcomes.
Working closely with PwP and healthcare professionals, a physical health education programme was co-designed to address the needs and preferences of PwP around exercise and PA education. The process was supervised by the patient and Public Involvement group attended by PwP, academics, researchers and clinicians working with PwP.
The study will utilise an assessor blinded randomised controlled design to investigate the acceptability and feasibility of delivering an online physical health education programme for PwP who are newly diagnosed. Thirty PwP, diagnosed in the last 12-months, will be randomly allocated into two groups: 1) the intervention group in which participants will receive online education modules and will be invited to attend virtual group sessions with a specialist neuro-physiotherapist; 2) the control group which will follow the usual care pathway and participants will receive Parkinson's UK booklets.
The aim of the study is to explore an alternative approach to standard care regarding patient education in PD and evaluate the feasibility and acceptability of a co-designed education intervention for newly diagnosed PwP delivered online. Feasibility data will be collected during the study and acceptability data will be assessed via a questionnaire at the end. Outcomes including PA levels, exercise knowledge, exercise efficacy, and participation will be assessed at baseline, post-intervention and at 6 months.
研究者
Ledia Alushi
PhD Student
University of Cambridge
入排标准
入选标准
- •Clinical diagnosis of Idiopathic Parkinson's Disease
- •Within 12 months since diagnosis
- •Stable medication regime for four weeks prior to initiation of trial
- •Ability to understand written English
排除标准
- •Acute illness
- •History of neurological disorder other than Parkinson Disease
- •Diagnosis of dementia or significant cognitive impairments
- •Participation in NHS structured PD-specific education program with or without exercise classes in the last year
- •Unable to understand written English
结局指标
主要结局
Acceptability assessment 3: Drop out rate
时间窗: Through study completion (12 months)
Comparison of drop out rates (%) between the intervention group and control group
Feasibility of delivering the intervention online
时间窗: Through study completion (12 months)
Assessment of any technical problems or difficulties accessing online intervention as reported by participants
Acceptability assessment 4: Acceptability of Intervention
时间窗: Completed at the end of participation in the study (after 8 weeks)
A questionnaire designed to assess satisfaction with the education intervention. it includes multiple choice and open ended questions.
Acceptability assessment 1: Recruitment rate
时间窗: Through study completion (12 months)
Assessment of recruitment rate of study (% of eligible participants enrolled)
Acceptability assessment 2: Education programme compliance
时间窗: Through study completion (12 months)
Compliance with the online education programme (% of sessions completed)
次要结局
- MiniBESTest(Baseline(week 0) and follow up (6-month post intervention))
- Self-efficacy for Exercise(Baseline(week 0), post intervention (week 8) and follow up (6-month post intervention))
- Hospital Anxiety and Depression Scale(Baseline(week 0), post intervention (week 8) and follow up (6-month post intervention))
- Multidimensional Outcome Expectation Scale(Baseline(week 0), post intervention (week 8) and follow up (6-month post intervention))
- Unified Parkinson's Disease Rating Scale Part 3(Baseline(week 0) and follow up (6-month post intervention))
- Oxford Participation and Activities Questionnaire(Baseline(week 0), post intervention (week 8) and follow up (6-month post intervention))
- Wrist-worn accelerometer(Baseline(week 0), post intervention (week 8) and follow up (6-month post intervention))
- Apathy Evaluation Scale(Baseline(week 0), post intervention (week 8) and follow up (6-month post intervention))
- Knowledge of Exercise and Physical Activity(Baseline(week 0), post intervention (week 8) and follow up (6-month post intervention))
- Five time Sit To Stand(Baseline(week 0) and follow up (6-month post intervention))
- Recent Physical Activity Questionnaire(Baseline(week 0), post intervention (week 8) and follow up (6-month post intervention))