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

NCT03111472 | Unknown

• 1 other identifier: 25364
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Parkinson Disease; Accidental Fall

Outcome Measures

Primary Outcomes (2)

• Feasibility and acceptability of the guide

  This will assessed through response to a questionnaire, with responses analysed through descriptive statistics

  3 months

• 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 Outcomes (2)

• Health related quality of life of people with Parkinson's as measured on PDQ8

  3 months

• Caregiver burden of their informal caregivers as measured on the Zarit Burden Interview scale short version

  3 months

Study Arms (1)

Self-management guide for falls in Parkinson's

EXPERIMENTAL

A guide for people with Parkinson's and their caregivers to self-manage falls.

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

Interventions

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

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.

Self-management guide for falls in Parkinson's

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southampton: lead
• National Institute for Health Research, United Kingdom: collaborator

Study Sites (1)

University of Southampton

Southampton, Hampshire, SO17 1BJ, United Kingdom

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 30-40 participants will receive the intervention. The intervention will be a guide to help people with Parkinson's and their caregivers to self-manage falls. There will be no control group.

Study Record Dates

• First Submitted: March 7, 2017
• First Posted: April 12, 2017
• Study Start: May 1, 2017
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: October 26, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)