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Development and Evaluation of a Guide to Help People With Parkinson's and Their Caregivers to Self-manage Falling

U

University of Southampton

Status

Unknown

Conditions

Parkinson Disease
Accidental Fall

Treatments

Other: Self-management guide for people with Parkinson's who fall and their informal caregivers

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

This study will investigate whether it is possible, through the development and evaluation of a self-management guide, to improve health related quality of life and concern of falling in people with Parkinson's disease who fall, and reduce caregiver burden in their informal caregivers.

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

40 participants in 1 patient group

Self-management guide for falls in Parkinson's
Experimental group
Description:
A guide for people with Parkinson's and their caregivers to self-manage falls.
Treatment:
Other: Self-management guide for people with Parkinson's who fall and their informal caregivers

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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