Development and Evaluation of a Guide to Help People With Parkinson's and Their Caregivers to Self-manage Falling
NCT ID: NCT03111472
Last Updated: 2017-10-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2017-05-01
2018-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Self-management guide for falls in Parkinson's
A guide for people with Parkinson's and their caregivers to self-manage falls.
Self-management guide for people with Parkinson's who fall and their informal caregivers
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.
Interventions
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Self-management guide for people with Parkinson's who fall and their informal caregivers
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* People with Parkinson's living in a residential or nursing home
* No falls in the preceding year
* Non-fluent in verbal and written English
18 Years
ALL
Yes
Sponsors
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National Institute for Health Research, United Kingdom
OTHER_GOV
University of Southampton
OTHER
Responsible Party
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Locations
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University of Southampton
Southampton, Hampshire, United Kingdom
Countries
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Other Identifiers
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25364
Identifier Type: -
Identifier Source: org_study_id