Parkinson DiseaseHOBSCOTCH-PDNCT06260228
HOme-Based Self-management and COgnitive Training CHanges Lives (HOBSCOTCH)-Parkinson's Disease (HOBSCOTCH-Parkinson's)
A study testing HOme-Based Self-management and COgnitive Training CHanges lives (HOBSCOTCH) in people with Parkinson Disease and Cognitive Dysfunction, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Parkinson Disease, Cognitive Dysfunction, Memory Disorders
- What is being tested?
- HOme-Based Self-management and COgnitive Training CHanges lives (HOBSCOTCH)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jan 2024to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Cognitive dysfunction that precludes participation in giving informed consent
- Significant visual impairment precluding reading or writing
- No reliable telephone or internet access
Trial locations and contacts
1 site in 1 country.
About this study
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:
Read more
- Can the current HOBSCOTCH program be adapted for people with PD?
- 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
- Conditions
- Parkinson Disease, Cognitive Dysfunction, Memory Disorders
- Being tested
- HOme-Based Self-management and COgnitive Training CHanges lives (HOBSCOTCH)
- Keywords
- Parkinson Disease, Memory, Cognitive Training, Self-Management
- Medical subject headings
- Parkinson Disease, Cognitive Dysfunction, Memory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HOme-Based Self-management and COgnitive Training CHanges lives (HOBSCOTCH)Behavioural
Also called HOBSCOTCH-PD
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Behavioral: HOme-Based Self-management and COgnitive Training CHanges lives (HOBSCOTCH) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: Baseline (pre-HOBSCOTCH-PD) and post-HOBSCOTCH-PD, approximately 9 weeks later.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2024
- Study start5 Jan 2024
- Primary completion26 Sep 2025
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elaine T. Kiriakopoulos, Dartmouth-Hitchcock Medical Center
- Investigators
- Elaine T Kiriakopoulos, MD, MPH, MSc, Principal investigator, Dartmouth-Hitchcock, Dartmouth College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06260228
- Sponsor's protocol ID
- STUDY02002270
- Acronym
- HOBSCOTCH-PD
- Status last verified
- Dec 2025
- First submitted
- 29 Jan 2024
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HOme-Based Self-management and COgnitive Training CHanges Lives (HOBSCOTCH)-Parkinson's Disease (HOBSCOTCH-Parkinson's)
- ClinicalTrials.gov ID
- NCT06260228
- Acronym / sponsor ID
- HOBSCOTCH-PD / STUDY02002270
- Conditions
- Parkinson Disease, Cognitive Dysfunction, Memory Disorders
- Keywords
- Parkinson Disease, Memory, Cognitive Training, Self-Management
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Study start
- 5 Jan 2024 (actual)
- Primary completion
- 26 Sep 2025 (actual)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 15 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Can the current HOBSCOTCH program be adapted for people with PD?
- 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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PD Participant with Cognitive Dysfunction | Other | Behavioral: HOme-Based Self-management and COgnitive Training CHanges lives (HOBSCOTCH)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) |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Cognitive dysfunction that precludes participation in giving informed consent
- Significant visual impairment precluding reading or writing
- No reliable telephone or internet access
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HOme-Based Self-management and COgnitive Training CHanges lives (HOBSCOTCH)Also: HOBSCOTCH-PDHOBSCOTCH 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. | Behavioural | PD Participant with Cognitive Dysfunction |
Primary outcome
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).
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elaine T Kiriakopoulos, MD, MPH, MSc principal investigator
Dartmouth-Hitchcock, Dartmouth College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HOme-Based Self-management and COgnitive Training CHanges lives (HOBSCOTCH) in people with Parkinson Disease and Cognitive Dysfunction, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.