KEEP Intervention for People Newly Diagnosed With Parkinson's

Parkinson Disease Clinical Trial

— KEEP  

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05253040
• Other study ID #: A096150
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 18, 2022
• Est. completion date: June 18, 2023

Study information

• Verified date: November 2022
• Source: University of Cambridge
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: June 18, 2023
• Est. primary completion date: September 21, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Other:
• KEEP Intervention
Educational intervention
• control
booklet from Parkinson's UK

Locations

Country	Name	City	State
United Kingdom	Department of Psychiatry	Cambridge

Sponsors (1)

Lead Sponsor	Collaborator
University of Cambridge

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptability assessment 1: Recruitment rate	Assessment of recruitment rate of study (% of eligible participants enrolled)	Through study completion (12 months)
Primary	Acceptability assessment 2: Education programme compliance	Compliance with the online education programme (% of sessions completed)	Through study completion (12 months)
Primary	Acceptability assessment 3: Drop out rate	Comparison of drop out rates (%) between the intervention group and control group	Through study completion (12 months)
Primary	Acceptability assessment 4: Acceptability of Intervention	A questionnaire designed to assess satisfaction with the education intervention. it includes multiple choice and open ended questions.	Completed at the end of participation in the study (after 8 weeks)
Primary	Feasibility of delivering the intervention online	Assessment of any technical problems or difficulties accessing online intervention as reported by participants	Through study completion (12 months)
Secondary	Unified Parkinson's Disease Rating Scale Part 3	The UPDRS is the gold-standard scale for Parkinson's assessment and has four parts. For this study only UPDRS III, motor examination will be completed by a trained assessor. UPDRS III total scores range from 7 to 86 points, with higher scores indicating more severe impairment..	Baseline(week 0) and follow up (6-month post intervention)
Secondary	MiniBESTest	The Mini-BEST is a 14-item scale that assesses dynamic balance components including anticipatory postural adjustments, reactive postural control, sensory orientation and dynamic gait. The data is based on a total score of 28 points, with higher score indicating better task performance.	Baseline(week 0) and follow up (6-month post intervention)
Secondary	Five time Sit To Stand	Five time sit to stand is a validated test used to assess functional lower extremity strength, balance and risk falls in older adults. It has been used in PD population with high interrater and test-retest reliability. Longer time to complete indicates worse task performance.	Baseline(week 0) and follow up (6-month post intervention)
Secondary	Self-efficacy for Exercise	The Self-Efficacy for exercise (SEE) scale is a 9-item validated scale which assesses a person self-efficacy to exercise under different circumstances. This scale is a modified version of Bandura's Exercise Self-Efficacy Scale and ask participants to rate their perceived exercise efficacy on a scale form 0 meaning not confident at all to 10 meaning very confident. Higher score indicate higher self-efficacy	Baseline(week 0), post intervention (week 8) and follow up (6-month post intervention)
Secondary	Hospital Anxiety and Depression Scale	Hospital Anxiety and Depression Scale (HADS) is a widely used questionnaire to measure anxiety and depression. A self-reported brief instrument which includes 14 questions aiming to detect and indicate severity of anxiety and depression. It has been used before and is a validated and reliable tool to use in Parkinson's population.	Baseline(week 0), post intervention (week 8) and follow up (6-month post intervention)
Secondary	Apathy Evaluation Scale	Apathy Evaluation Scale (AES) is a standardised and validated self-rating instrument to evaluate apathy. It consists of 18 items that are scored on a 4-point Likert Scale, with highest score indicating more severe apathy	Baseline(week 0), post intervention (week 8) and follow up (6-month post intervention)
Secondary	Multidimensional Outcome Expectation Scale	Outcome expectations about the benefits of regular exercise and PA will be measured by the Multidimensional Outcomes Expectations for Exercise Scale (MOEES). The MOEES has 15 items that reflect three subdomains of outcome expectations. The items were rated on a five-point scale from 1 (Strongly disagree) to 5 (Strongly agree) and summed to form the subscale measures of outcome expectations with higher scores reflecting greater beliefs about the benefits of regular exercise and physical activity.	Baseline(week 0), post intervention (week 8) and follow up (6-month post intervention)
Secondary	Oxford Participation and Activities Questionnaire	Oxford Participation and Activities Questionnaire (Ox-PAQ) is a patient-reported outcome measure comprised of 23 items aiming to assess participation and activity in patients with long-term conditions.	Baseline(week 0), post intervention (week 8) and follow up (6-month post intervention)
Secondary	Recent Physical Activity Questionnaire	Physical Activity will be measured subjectively and objectively. Subjectively it will be measured via the self-reported Recent Physical Activity Questionnaire (RPAQ), which is designed to assess PA in everyday life in the last 4 weeks. The questionnaire has three sections assessing a range of activities in different domains (around the house, work and recreation).	Baseline(week 0), post intervention (week 8) and follow up (6-month post intervention)
Secondary	Knowledge of Exercise and Physical Activity	Knowledge of Exercise and Physical Activity questionnaire is a 10-item knowledge questionnaire around the role of exercise and physical activity in the management of PD and it has been designed by the PI to assess knowledge levels. A total score of 10 indicates better knowledge scores.	Baseline(week 0), post intervention (week 8) and follow up (6-month post intervention)
Secondary	Wrist-worn accelerometer	Objectively, physical activity will be measured with the use of a wrist-worn accelerometer (GeneActiv monitor) over 7 consecutive days.	Baseline(week 0), post intervention (week 8) and follow up (6-month post intervention)