NCT06260228

Brief Summary

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:

  • 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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable parkinson-disease

Timeline
3mo left

Started Jan 2024

Typical duration for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress91%
Jan 2024Jul 2026

Study Start

First participant enrolled

January 5, 2024

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

January 29, 2024

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 15, 2024

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 26, 2025

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2026

Expected
Last Updated

December 18, 2025

Status Verified

December 1, 2025

Enrollment Period

1.7 years

First QC Date

January 29, 2024

Last Update Submit

December 11, 2025

Conditions

Keywords

Parkinson DiseaseMemoryCognitive TrainingSelf-Management

Outcome Measures

Primary Outcomes (2)

  • Change in quality of life as measured by comparing PDQ-39 (Parkinson's Disease Questionnaire) scores pre- and post-HOBSCOTCH-PD intervention.

    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.

    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.

Study Arms (1)

PD Participant with Cognitive Dysfunction

OTHER

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)

Interventions

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.

Also known as: HOBSCOTCH-PD
PD Participant with Cognitive Dysfunction

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dartmouth-Hitchcock

Lebanon, New Hampshire, 03756, United States

Location

MeSH Terms

Conditions

Parkinson DiseaseCognitive DysfunctionMemory Disorders

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesCognition DisordersNeurocognitive DisordersMental DisordersNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Elaine T Kiriakopoulos, MD, MPH, MSc

    Dartmouth-Hitchcock, Dartmouth College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Neurology, Geisel School of Medicine at Dartmouth Director, HOBSCOTCH Institute for Cognitive Health & Well-Being Dartmouth Hitchcock Epilepsy Center

Study Record Dates

First Submitted

January 29, 2024

First Posted

February 15, 2024

Study Start

January 5, 2024

Primary Completion

September 26, 2025

Study Completion (Estimated)

July 30, 2026

Last Updated

December 18, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations