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OpenTrials
Completed

NCT Number: NCT03275649

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

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

City, University of London

London, EC1V 0HB, United Kingdom

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Help-seeking for non-motor symptoms

Other

Brief, self-paced, online individually tailored intervention using LifeGuide software. Includes information, videos and exercises.

Primary outcomes

  1. Proportion of patients help-seeking post-intervention

    Time frame: 1 week

    after intervention

Secondary outcomes

  1. Number of eligible patients completing the study

    Time frame: 1 week

Sponsors and collaborators

Lead sponsor

City, University of London

Other

Collaborators

  • King's College Hospital NHS Trust
  • King's College London

Registry information

Official study title

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

Acronym: PDHelp

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 7, 2017
Registry last updated
Jan 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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