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

Parkinson Disease Clinical Trial

— HOBSCOTCH-PD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06260228
• Other study ID #: STUDY02002270
• Status: Recruiting
• Phase: N/A
• Start date: January 5, 2024
• Est. completion date: November 30, 2024

Study information

• Verified date: February 2024
• Source: Dartmouth-Hitchcock Medical Center
• Contact: Sarah J Kaden, MA
• Phone: 6035405824
• Email: sarah.j.kaden[@]hitchcock.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5
• Est. completion date: November 30, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Memory Disorders
• Parkinson Disease

Intervention

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.

Locations

Country	Name	City	State
United States	Dartmouth-Hitchcock	Lebanon	New Hampshire

Sponsors (1)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.