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

Parkinson Disease Clinical Trial

Official title:

Development and Evaluation of a Self-management Guide for Community-dwelling People With Parkinson's Disease Who Fall and Their Informal Caregivers

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03111472
• Other study ID #: 25364
• Status: Active, not recruiting
• Phase: N/A
• First received: March 7, 2017
• Last updated: October 24, 2017
• Start date: May 1, 2017
• Est. completion date: December 2018

Study information

• Verified date: October 2017
• Source: University of Southampton
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Accidental Fall
• Parkinson Disease

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United Kingdom	University of Southampton	Southampton	Hampshire

Sponsors (2)

Lead Sponsor	Collaborator
University of Southampton	National Institute for Health Research, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility and acceptability of the guide	This will assessed through response to a questionnaire, with responses analysed through descriptive statistics	3 months
Primary	Feasibility and acceptability of the guide	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	Health related quality of life of people with Parkinson's as measured on PDQ8	As measured on Parkinson's disease quality of life scale 8 (PDQ8)	3 months
Secondary	Caregiver burden of their informal caregivers as measured on the Zarit Burden Interview scale short version	As measured on the Zarit Burden Interview scale short form	3 months