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Clinical Trials/NCT03275649
NCT03275649
Completed
Not Applicable

Development of an Intervention to Increase Help-seeking for Non-motor Symptoms in People With Parkinson's

City, University of London1 site in 1 country35 target enrollmentJuly 21, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Parkinson Disease
Sponsor
City, University of London
Enrollment
35
Locations
1
Primary Endpoint
Proportion of patients help-seeking post-intervention
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

Non-motor symptoms (NMS) are common in Parkinson's disease (PD) and cause significant distress and decreased quality of life. A high rate of non-declaration of NMS by patients means that many NMS remain unrecognized and untreated, even in specialist clinical services. In phase one of this research qualitative interviews (phase 1) were guided by the Theoretical Domains Framework and used to identify the barriers for help-seeking. A quantitative questionnaire survey (phase 2) examined the significance of these barriers to help seeking. The present study aims to develop (phase 3) and test the feasibility (phase 4) of a targeted behavioural intervention of barriers which were identified in phases 1 and 2 which prevent help-seeking for NMS in patients with PD. As with phases 1 and 2, the feasibility trial will include people with unreported burdensome NMS, who have not reported them to their PD consultant or nurse. The intervention has been co-designed by people affected by Parkinson's and targets the barriers identified in the previous phases of the research. In phase three of the research, 'think-aloud' interviews will be used to further develop the intervention so that it is acceptable and easy to use. In the final phase, a feasibility trial will be conducted to examine efficacy of the intervention for increasing help-seeking for undeclared NMS. The study has implications for using a theoretically driven behavioural intervention to promote help-seeking for NMS and ultimately increase receipt of clinical care for NMS among patients with PD.

Registry
clinicaltrials.gov
Start Date
July 21, 2017
End Date
January 1, 2018
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Diagnosis of idiopathic Parkinson's
  • Access to a computer and internet connection
  • Experiencing at least one unreported non-motor symptom

Exclusion Criteria

  • Presence of sensory loss or communication difficulty (including inadequate command of English) sufficient to interfere with the assessments.
  • Severe cognitive impairment that would make participation in the intervention problematic or distressing. This will be assessed using the Telephone Interview for Cognitive Status-Modified (TICS-M, Brandt et al., 1993). People with a score of less than 20 will be excluded.

Outcomes

Primary Outcomes

Proportion of patients help-seeking post-intervention

Time Frame: 1 week

after intervention

Secondary Outcomes

  • Number of eligible patients completing the study(1 week)

Study Sites (1)

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