Clinical trial NCT05253040: KEEP Intervention for People Newly Diagnosed With Parkinson's
Official title: 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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Keywords: Physical activity
education
exercise
self-efficacy
Lead sponsor: University of Cambridge
Sponsor class: OTHER
First posted: 2022-02-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Acceptability assessment 1: Recruitment rate
timeFrame: Through study completion (12 months)
measure: Acceptability assessment 2: Education programme compliance
timeFrame: Through study completion (12 months)
measure: Acceptability assessment 3: Drop out rate
timeFrame: Through study completion (12 months)
measure: Acceptability assessment 4: Acceptability of Intervention
timeFrame: Completed at the end of participation in the study (after 8 weeks)
measure: Feasibility of delivering the intervention online
timeFrame: Through study completion (12 months)
Secondary outcomes:
measure: Unified Parkinson's Disease Rating Scale Part 3
timeFrame: Baseline(week 0) and follow up (6-month post intervention)
measure: MiniBESTest
timeFrame: Baseline(week 0) and follow up (6-month post intervention)
measure: Five time Sit To Stand
timeFrame: Baseline(week 0) and follow up (6-month post intervention)
measure: Self-efficacy for Exercise
timeFrame: Baseline(week 0), post intervention (week 8) and follow up (6-month post intervention)
measure: Hospital Anxiety and Depression Scale
timeFrame: Baseline(week 0), post intervention (week 8) and follow up (6-month post intervention)
measure: Apathy Evaluation Scale
timeFrame: Baseline(week 0), post intervention (week 8) and follow up (6-month post intervention)
measure: Multidimensional Outcome Expectation Scale
timeFrame: Baseline(week 0), post intervention (week 8) and follow up (6-month post intervention)
measure: Oxford Participation and Activities Questionnaire
timeFrame: Baseline(week 0), post intervention (week 8) and follow up (6-month post intervention)
measure: Recent Physical Activity Questionnaire
timeFrame: Baseline(week 0), post intervention (week 8) and follow up (6-month post intervention)
measure: Knowledge of Exercise and Physical Activity
timeFrame: Baseline(week 0), post intervention (week 8) and follow up (6-month post intervention)
measure: Wrist-worn accelerometer
timeFrame: Baseline(week 0), post intervention (week 8) and follow up (6-month post intervention)
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Department of Psychiatry
Study officials:
References: