Help-seeking for Health Problems in People With Parkinson's

Parkinson Disease Clinical Trial

— PDHelp  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03275649
• Other study ID #: CityULondon_PDHelp
• Status: Completed
• Phase: N/A
• First received: August 29, 2017
• Last updated: January 29, 2018
• Start date: July 21, 2017
• Est. completion date: January 1, 2018

Study information

• Verified date: January 2018
• Source: City, University of London
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: January 1, 2018
• Est. primary completion date: January 1, 2018
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Other:
• Help-seeking for non-motor symptoms
Brief, self-paced, online individually tailored intervention using LifeGuide software. Includes information, videos and exercises.

Locations

Country	Name	City	State
United Kingdom	City, University of London	London

Sponsors (3)

Lead Sponsor	Collaborator
City, University of London	King's College Hospital NHS Trust, King's College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients help-seeking post-intervention	after intervention	1 week
Secondary	Number of eligible patients completing the study		1 week