EpilepsyNCT06462911
Epilepsy Self-Management for Spanish Speakers: HOBSCOTCH - ESPANOL
A study testing HOme-Based Self-management and COgnitive Training CHanges lives (HOBSCOTCH) - Spanish/Espanol in people with Epilepsy 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 translating and delivering the existing home-based epilepsy self-management intervention, HOBSCOTCH, for people with epilepsy whose primary language is Spanish. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epilepsy, Cognitive Dysfunction, Memory Disorders
- What is being tested?
- HOme-Based Self-management and COgnitive Training CHanges lives (HOBSCOTCH) - Spanish/Espanol
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2024to Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (18 + years)
- Self-reported epilepsy with controlled or uncontrolled seizures
- Spanish as primary language
- Literate in Spanish (per bilingual Cognitive Coach)
- Access to the internet and/or a telephone
Who cannot join
- Self-report of a dementing illness, a dementing illness appearing in their medical record if available or in the judgment of the Principal Investigator or Bilingual Coach
- Severe mental disability or estimated IQ less than 70 per clinical judgement of the Principal Investigator or Bilingual Coach
- Significant visual impairment precluding reading or writing
- No reliable telephone or internet access
- No self-reported diagnosis of epilepsy
Trial locations and contacts
1 site in 1 country.
United States1 site
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
About this study
Official title: HOme-Based Self-management and COgnitive Training CHanges Lives (HOBSCOTCH) - SPANISH/ESPAÑOL
The goal of this pilot study is to assess the feasibility of translating and delivering the existing home-based epilepsy self-management intervention, HOBSCOTCH, for people with epilepsy whose primary language is Spanish.
The main questions it aims to answer are:
Read more
- Can the current HOBSCOTCH program be successfully translated for Spanish speaking people with epilepsy?
- Will people with epilepsy who speak Spanish experience improved quality of life similar to that found in people with epilepsy who received the HOBSCOTCH program in English?
Participants will be asked to:
- attend nine, one-hour virtual (online and/or by telephone) HOBSCOTCH-SPANISH sessions with a one-on-one certified bilingual HOBSCOTCH coach
- complete a brief clinical questionnaire about their diagnosis of epilepsy
- complete two questionnaires before and after the HOBSCOTCH sessions about their quality of life and about memory and thinking processes
- keep a short daily diary about their seizures, symptoms and use of the self-management strategies taught in the HOBSCOTCH program
- complete a brief Satisfaction Survey and a 3 question survey about shared decision making after the entire HOBSCOTCH program
- Conditions
- Epilepsy, Cognitive Dysfunction, Memory Disorders
- Being tested
- HOme-Based Self-management and COgnitive Training CHanges lives (HOBSCOTCH) - Spanish/Espanol
- Keywords
- Epilepsy, Memory, Cognitive training, Self management
- Medical subject headings
- Epilepsy, 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) - Spanish/EspanolBehavioural
Also called HOBSCOTCH-Spanish/Espanol
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. The entire HOBSCOTCH program has been translated into Spanish for people with epilepsy who speak Spanish.
| Study group | Role | What they receive |
|---|---|---|
| Spanish speaking participant with self-reported epilepsy and cognitive and memory dysfunction | Experimental | Participants will receive the HOBSCOTCH intervention (in Spanish) 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) - Spanish/Espanol |
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 the pre and post HOBSCOTCH-Spanish/Espanol intervention scores on the Quality of Life in Epilepsy-10 (QOLIE-10).
The QOLIE-10 is a standard, brief questionnaire that asks people with epilepsy about the impact of their condition on their lives. It consists of 10 questions based on a 5-point Likert scale ranging from "none of the time or not at all" to "all of the time or extremely." The scoring ensures that positive responses are represented by lower numbers, while negative responses correspond to higher numbers. The total score is calculated by summing the scores for all answered questions and dividing by the number of items answered. Patients with lower scores experience fewer problems related to their epilepsy.
Measured: Before the HOBSCOTCH program and after the HOBSCOTCH program, approximately 9 weeks later.
Change in subjective cognition as measured by comparing the pre and post HOBSCOTCH-Spanish/Espanol intervention scores on NeuroQOL - Cognitive Function sub-scale.
The Cognitive Function sub-scale of the NeuroQOL 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: Before the HOBSCOTCH program and after the HOBSCOTCH program, approximately 9 weeks later.
Secondary outcomes (2)
Participant satisfaction with the HOBSCOTCH-Spanish/Espanol program as measured by analyzing a Participant Satisfaction Survey at the end of the study.
The Participant Satisfaction Survey has been developed through the original HOBSCOTH program and is used in clinical practice for quality improvement and was translated into Spanish. It contains 10 items scored on a 5-point Likert scale with a higher score indicating greater satisfaction with the program.
Measured: After the completion of the HOBSCOTCH-Spanish/Espanol program, approximately 9 weeks later.
Evaluation of participants' perception of shared-decision making during HOBSCOTCH-Spanish/Espanol intervention as measured by CollaboRATE score.
CollaboRATE is a brief patient survey focused on shared decision making. It employs a 3-item assessment of patient perception of how much effort was made to hear, understand and incorporate their concerns into the program. The items are measured on a 10-point Likert scale in which 0 indicates that no effort was made and 9 indicates every effort was made. Higher scores indicate a greater degree or positive impression of patient perception of shared decision making.
Measured: After the completion of the HOBSCOTCH-Spanish/Espanol program, 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 posted17 Jun 2024
- Study startSep 2024 (estimated)
- Primary completionJan 2025 (estimated)
- Study completionMar 2025 (estimated)
Why it stopped: The project has been revised and will be considered not human research.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies 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
- 0 participants (actual)
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-Health/Dartmouth-Hitchcock, Dartmouth College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06462911
- Sponsor's protocol ID
- STUDY02002468
- Status last verified
- Aug 2024
- First submitted
- 14 May 2024
- Last updated
- 30 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2024. 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) - SPANISH/ESPAÑOL
- ClinicalTrials.gov ID
- NCT06462911
- Acronym / sponsor ID
- STUDY02002468
- Conditions
- Epilepsy, Cognitive Dysfunction, Memory Disorders
- Keywords
- Epilepsy, Memory, Cognitive training, Self management
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The project has been revised and will be considered not human research.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Study start
- Sep 2024 (estimated)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 17 Jun 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 translating and delivering the existing home-based epilepsy self-management intervention, HOBSCOTCH, for people with epilepsy whose primary language is Spanish.
The main questions it aims to answer are:
- Can the current HOBSCOTCH program be successfully translated for Spanish speaking people with epilepsy?
- Will people with epilepsy who speak Spanish experience improved quality of life similar to that found in people with epilepsy who received the HOBSCOTCH program in English?
Participants will be asked to:
- attend nine, one-hour virtual (online and/or by telephone) HOBSCOTCH-SPANISH sessions with a one-on-one certified bilingual HOBSCOTCH coach
- complete a brief clinical questionnaire about their diagnosis of epilepsy
- complete two questionnaires before and after the HOBSCOTCH sessions about their quality of life and about memory and thinking processes
- keep a short daily diary about their seizures, symptoms and use of the self-management strategies taught in the HOBSCOTCH program
- complete a brief Satisfaction Survey and a 3 question survey about shared decision making after the entire HOBSCOTCH program
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spanish speaking participant with self-reported epilepsy and cognitive and memory dysfunction | Experimental | Behavioral: HOme-Based Self-management and COgnitive Training CHanges lives (HOBSCOTCH) - Spanish/EspanolParticipants will receive the HOBSCOTCH intervention (in Spanish) 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
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult (18 + years)
- Self-reported epilepsy with controlled or uncontrolled seizures
- Spanish as primary language
- Literate in Spanish (per bilingual Cognitive Coach)
- Access to the internet and/or a telephone
Key exclusion criteria (5 listed)
- Self-report of a dementing illness, a dementing illness appearing in their medical record if available or in the judgment of the Principal Investigator or Bilingual Coach
- Severe mental disability or estimated IQ less than 70 per clinical judgement of the Principal Investigator or Bilingual Coach
- Significant visual impairment precluding reading or writing
- No reliable telephone or internet access
- No self-reported diagnosis of epilepsy
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) - Spanish/EspanolAlso: HOBSCOTCH-Spanish/EspanolHOBSCOTCH 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. The entire HOBSCOTCH program has been translated into Spanish for people with epilepsy who speak Spanish. | Behavioural | Spanish speaking participant with self-reported epilepsy and cognitive and memory dysfunction |
Primary outcome
Change in quality of life as measured by comparing the pre and post HOBSCOTCH-Spanish/Espanol intervention scores on the Quality of Life in Epilepsy-10 (QOLIE-10).
Time frame: Before the HOBSCOTCH program and after the HOBSCOTCH program, approximately 9 weeks later.
The QOLIE-10 is a standard, brief questionnaire that asks people with epilepsy about the impact of their condition on their lives. It consists of 10 questions based on a 5-point Likert scale ranging from "none of the time or not at all" to "all of the time or extremely." The scoring ensures that positive responses are represented by lower numbers, while negative responses correspond to higher numbers. The total score is calculated by summing the scores for all answered questions and dividing by the number of items answered. Patients with lower scores experience fewer problems related to their epilepsy.
Change in subjective cognition as measured by comparing the pre and post HOBSCOTCH-Spanish/Espanol intervention scores on NeuroQOL - Cognitive Function sub-scale.
Time frame: Before the HOBSCOTCH program and after the HOBSCOTCH program, approximately 9 weeks later.
The Cognitive Function sub-scale of the NeuroQOL 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.
2 secondary outcomes
Participant satisfaction with the HOBSCOTCH-Spanish/Espanol program as measured by analyzing a Participant Satisfaction Survey at the end of the study.
Time frame: After the completion of the HOBSCOTCH-Spanish/Espanol program, approximately 9 weeks later.
Evaluation of participants' perception of shared-decision making during HOBSCOTCH-Spanish/Espanol intervention as measured by CollaboRATE score.
Time frame: After the completion of the HOBSCOTCH-Spanish/Espanol program, approximately 9 weeks later.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2024.
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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-Health/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) - Spanish/Espanol in people with Epilepsy 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 5 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: withdrawn, as of the sponsor's last update on 30 Aug 2024. 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?
The study was withdrawn before enrolling participants, so there are no results.
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 the pre and post HOBSCOTCH-Spanish/Espanol intervention scores on the Quality of Life in Epilepsy-10 (QOLIE-10). (time frame: Before the HOBSCOTCH program and after the HOBSCOTCH program, 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 30 Aug 2024.