HOme-Based Self-management and COgnitive Training CHanges Lives (HOBSCOTCH)-Parkinson's Disease (HOBSCOTCH-Parkinson's) (HOBSCOTCH-PD)

February 13, 2024 updated by: Elaine T. Kiriakopoulos, Dartmouth-Hitchcock Medical Center

The goal of this pilot study is to assess the feasibility of adapting and delivering the existing home-based epilepsy self-management intervention, HOBSCOTCH, for people with Parkinson's Disease (PD)

The main questions it aims to answer are:

  1. Can the current HOBSCOTCH program be adapted for people with PD?
  2. Will people with PD experience improved quality of life similar to that found in people with epilepsy after participating in the HOBSCOTCH program?

Participants will be asked to:

  • attend nine, one-hour virtual (online and/or by telephone) HOBSCOTCH-PD sessions with a one-on-one certified HOBSCOTCH-PD coach
  • complete a brief clinical questionnaire about their diagnosis of PD
  • complete two questionnaires before and after the HOBSCOTCH-PD sessions about their quality of life and about memory and thinking processes
  • keep a short daily diary about their PD symptoms and use of the self-management strategies taught in the HOBSCOTCH-PD program
  • complete a brief Satisfaction Survey after the entire HOBSCOTCH-PD program

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 30 - 75 years
  • Diagnosis of Parkinson's Disease per participant's provider
  • Literate, English-speaking with grade 12 or equivalent in education
  • Self-reported cognitive/memory difficulties
  • Telephone and internet access

Exclusion Criteria:

  • Cognitive dysfunction that precludes participation in giving informed consent
  • Significant visual impairment precluding reading or writing
  • No reliable telephone or internet access

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: PD Participant with Cognitive Dysfunction

Participants will receive the HOBSCOTCH-PD intervention consisting of 1:1 sessions delivered once per week including:

  • 1 pre-HOBSCOTCH Session (on webcam or by phone)
  • 1 educational session (on webcam)
  • 6 HOBSCOTCH intervention sessions (webcam or phone)
  • 1 wrap-up session (webcam or phone)
Behavioral: HOme-Based Self-management and COgnitive Training CHanges lives (HOBSCOTCH)
HOBSCOTCH is a home-based self-management program to treat cognitive symptoms and improve quality of life, while minimizing the barriers of access to care. The program is based on Problem Solving Therapy (PST) and teaches problem solving strategies and compensatory mechanisms to help manage cognitive dysfunction and enhance quality of life. HOBSCOTCH-PD is an adaptation of the HOBSCOTCH program for people with PD and incorporates education about Parkinson Disease and cognition into the education module.
Other Names:
  • HOBSCOTCH-PD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in quality of life as measured by comparing PDQ-39 (Parkinson's Disease Questionnaire) scores pre- and post-HOBSCOTCH-PD intervention.
Time Frame: Baseline (pre-HOBSCOTCH-PD) and post-HOBSCOTCH-PD, approximately 9 weeks later.
The Parkinson's Disease Questionnaire (PDQ-39) is a 39-item validated, patient reported measure of quality of life. The questionnaire assesses how often people with PD experience difficulties across 8 dimensions of daily living including relationships, social situations and communication as well as the impact of Parkinson's on specific dimensions of functioning and wellbeing. The dimension scores are coded on a scale of 0 (perfect health as assessed by the measure) to 100 (worst health as assessed by the measure).
Baseline (pre-HOBSCOTCH-PD) and post-HOBSCOTCH-PD, approximately 9 weeks later.
Change in subjective cognition as measured by comparing Neuro-QOL Item Bank v2.0 Cognitive Function scores pre- and post-HOBSCOTCH-PD intervention.
Time Frame: Baseline (pre-HOBSCOTCH-PD) and post-HOBSCOTCH-PD, approximately 9 weeks later.
The Cognitive Function sub-scale of the Neuro-QOL is a brief validated tool developed by the NIH for use in patients with neurological disease. Scores range from 8 to 40, with a higher score indicating better reported cognitive functioning.
Baseline (pre-HOBSCOTCH-PD) and post-HOBSCOTCH-PD, approximately 9 weeks later.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dartmouth-Hitchcock Medical Center

Investigators

  • Principal Investigator: Elaine T Kiriakopoulos, MD, MPH, MSc, Dartmouth-Hitchcock, Dartmouth College

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 5, 2024

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

November 30, 2024

Study Registration Dates

First Submitted

January 29, 2024

First Submitted That Met QC Criteria

February 13, 2024

First Posted (Actual)

February 15, 2024

Study Record Updates

Last Update Posted (Actual)

February 15, 2024

Last Update Submitted That Met QC Criteria

February 13, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY02002270

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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