- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03111472
Development and Evaluation of a Guide to Help People With Parkinson's and Their Caregivers to Self-manage Falling
Development and Evaluation of a Self-management Guide for Community-dwelling People With Parkinson's Disease Who Fall and Their Informal Caregivers
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study will progress through four phases
Phase One
Establish the needs and preferences of people with Parkinson's (PwP) who fall and their informal caregivers for the effective self-management of falls. This will be achieved through questionnaires distributed to 30-40 PwP and their caregivers, with responses analysed through the use of descriptive statistics. A purposive sample of participants, selected through responses to the questionnaire, will be invited to participate in semi-structured interviews. Interviews will be conducted until data saturation has been achieved. These interviews will seek to further identify the thoughts and experiences of PwP and their caregivers in relation to falling, with responses analysed through thematic analysis.
Phase Two
Establish the needs and preferences of PwP who fall and their informal caregivers for the effective self-management of falls, as perceived by healthcare professionals specialising in the care of PwP. This will be achieved through semi-structured interviews and focus groups with 10 healthcare professionals involved in the care of PwP who fall. The interviews will be analysed with thematic analysis.
Phase Three
Development of a prototype of a self-management guide utilising information from phases one and two alongside a systematic review of self-management interventions for people with Parkinson's who fall. The prototype will be distributed to 6-8 dyads of PwP who fall and their caregivers. Feedback will be sought in the form of a questionnaire, with responses analysed through the use of descriptive statistics, and the guide modified accordingly.
Phase Four
Mixed methods acceptability and feasibility study of the modified version of the guide; with a before and after comparison of health related quality of life and concern of falling in PwP, and of caregiver burden in their informal caregivers.
The guide will be distributed to 30-40 pairings of PwP who fall and their caregivers. Baseline assessments of health related quality of life (Parkinson's disease questionnaire 8, PDQ8) and of caregiver burden (Zarit Burden Interview short version) will be completed.
After three months, participants will complete feedback questionnaires to assess the acceptability and the feasibility of the guide, and will repeat the PDQ8 and zarit burden Interview short version . The responses to the questionnaires will be analysed through the use of descriptive statistics, with a before and after comparison of health related quality of life and of caregiver burden.
A purposive sample of participants, selected through their responses to the questionnaires, will be invited to participate in semi-structured interviews, to further explore their thoughts about the guide. Interviews will be conducted until data saturation has been reached, we estimate that we will conduct 12-15 interviews. The interviews will be analysed using thematic analysis.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Hampshire
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Southampton, Hampshire, United Kingdom, SO17 1BJ
- University of Southampton
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Diagnosis of idiopathic Parkinson's disease, with or without cognitive impairment
- People with Parkinson's living in their own home
- At least one fall in the preceding year, as reported by the person with Parkinson's or the caregiver
- Able to read a newspaper without severe difficulty, with or without glasses
OR
- An informal caregiver of a person with Parkinson's meeting the criteria for inclusion in the study
Exclusion Criteria:
- Diagnosis of a Parkinson's Plus syndrome
- People with Parkinson's living in a residential or nursing home
- No falls in the preceding year
- Non-fluent in verbal and written English
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Self-management guide for falls in Parkinson's
A guide for people with Parkinson's and their caregivers to self-manage falls.
|
The self-management guide will be developed utilising information from people with Parkinson's, informal caregivers of people with Parkinson's, healthcare professionals and a systematic review of self-management interventions for people with Parkinson's who fall.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility and acceptability of the guide
Time Frame: 3 months
|
This will assessed through response to a questionnaire, with responses analysed through descriptive statistics
|
3 months
|
Feasibility and acceptability of the guide
Time Frame: 3 months
|
A purposive sample of participants, selected through their responses to the questionnaire, will be invited to participate in semi-structured interviews.
Interviews will explore the experiences and thoughts of the participants further and will be conducted until data saturation has been reached.
Responses to the interview will be analysed through thematic analysis.
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Health related quality of life of people with Parkinson's as measured on PDQ8
Time Frame: 3 months
|
As measured on Parkinson's disease quality of life scale 8 (PDQ8)
|
3 months
|
Caregiver burden of their informal caregivers as measured on the Zarit Burden Interview scale short version
Time Frame: 3 months
|
As measured on the Zarit Burden Interview scale short form
|
3 months
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 25364
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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