KEEP Intervention for People Newly Diagnosed With Parkinson's

University of Cambridge

Status: Active, not recruiting

Conditions: Parkinson Disease

Treatments: Other: KEEP Intervention; Other: control

Study type: Interventional

Funder types: Other

Identifiers

NCT05253040

A096150

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Intervention group

Experimental group

Description:

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

Treatment:

Other: KEEP Intervention

Control Group

Active Comparator group

Description:

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.

Treatment:

Other: control