KEEP Intervention for People Newly Diagnosed With Parkinson's

NCT05253040 | Unknown DMC

• 1 other identifier: A096150
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

Physical activity; education; exercise; self-efficacy

Outcome Measures

Primary Outcomes (5)

• Acceptability assessment 1: Recruitment rate

  Assessment of recruitment rate of study (% of eligible participants enrolled)

  Through study completion (12 months)

• Acceptability assessment 2: Education programme compliance

  Compliance with the online education programme (% of sessions completed)

  Through study completion (12 months)

• Acceptability assessment 3: Drop out rate

  Comparison of drop out rates (%) between the intervention group and control group

  Through study completion (12 months)

• 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)

• 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 Outcomes (11)

• Unified Parkinson's Disease Rating Scale Part 3

  Baseline(week 0) and follow up (6-month post intervention)

• MiniBESTest

  Baseline(week 0) and follow up (6-month post intervention)

• Five time Sit To Stand

  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)

Study Arms (2)

Intervention group

EXPERIMENTAL

The experimental group will receive: Online education modules Online group discussions facilitated by Specialist Physiotherapist

Other: KEEP Intervention

Control Group

ACTIVE COMPARATOR

The comparator for this study is usual care pathway. Under the usual care pathway, participants will receive education booklets on exercise by Parkinson's UK.

Other: control

Interventions

KEEP Intervention OTHER

Educational intervention

Intervention group

control OTHER

booklet from Parkinson's UK

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Cambridge: lead

Study Sites (1)

Department of Psychiatry

Cambridge, CB2 0SZ, United Kingdom

Location

Related Publications (1)

• Agley L, Hartley P, Duffill D, Iqbal A, Mackett A, Rennie KL, Lafortune L. Digital Intervention Promoting Physical Activity in People Newly Diagnosed with Parkinson's Disease: Feasibility and Acceptability of the Knowledge, Exercise-Efficacy and Participation (KEEP) Intervention. J Parkinsons Dis. 2024;14(6):1193-1210. doi: 10.3233/JPD-240071.

  PMID: 39093079 DERIVED

MeSH Terms

Conditions

Parkinson Disease; Motor Activity

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Student

Study Record Dates

• First Submitted: February 2, 2022
• First Posted: February 23, 2022
• Study Start: June 18, 2022
• Primary Completion: September 21, 2022
• Study Completion: June 18, 2023
• Last Updated: November 4, 2022

Record last verified: 2022-11

Locations

GB (1)