Huntington DiseaseNCT05268029
Making HD Voices Heard
An observational study of Huntington Disease, run by Huntington Study Group at 1 site in United States.
Trial summary
The Pilot Study, Making HD Voices Heard, will ask people living with HD to report what they experience and how they function. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Huntington Disease
- How many people
- 698 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Mar 2022to 11 Oct 2023
- Phase
- Observational
- 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
Study population: Individuals who have been diagnosed with Huntington disease.
Who may be able to join
- Adults age 18 years and older
- Willing and able to provide informed consent electronically.
- Individuals answering as a participant must self-report they have been diagnosed with HD by a doctor.
- Ability to answer online questions or direct someone else to enter answers for them.
- Ability to ambulate independently and take care of some of his or her personal needs.
- Ability to read and understand English.
Show all 9Show fewer
- Willing to create a unique identifier based on personal demographic information.
- Residing in the United States or its territories
- Owning or having access to an electronic device and secure internet connectivity
Who cannot join
- An individual who does not meet all the inclusion criteria will be excluded from participation in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Making HD Voices Heard - A Pilot Study on the myHDstory™ Platform
The Pilot Study, Making HD Voices Heard, will ask people living with HD to report what they experience and how they function.
Read the detailed description
The Huntington Study Group (HSG) myHDstory™ Platform is an online, observational research platform that will host the Pilot Study, Making HD Voices Heard. The Pilot Study will ask people living with HD to report what they experience and how they function. Participants will provide self-reported information using their own compatible smartphones, laptops, desktops, or tablets. Participants will be asked to reply to a series of questions, including open-ended questions that will be transcribed by voice (microphone voice-to-text transcription) or keyboard-entered text to record what they experience in their own words.
- Conditions
- Huntington Disease
- Medical subject headings
- Huntington Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
The ability to successfully consent and enroll at least 200 HD participants who have early to mid-stage manifest HD.
Ability to successfully consent and enroll at least 200 manifest HD participants (independent or with help of assistants) within three months as measured by the number of help line calls or emails received requesting technical or clinical support.
Measured: 3 months
Participants' ability to successfully complete online self-reported questionnaires.
Participants' ability to successfully complete online self-reported questionnaires as measured by the number of completed questionnaires.
Measured: 3 months
Utility and informativeness of data collected.
Utility and informativeness of capturing, extracting, curating, and analyzing verbatim responses to open-ended questions in the form of the HD-Patient Report of Problems (HD-PROP).
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2022
- Study start23 Mar 2022
- Primary completion11 Oct 2023
- Study completion11 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Huntington DiseaseStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 698 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huntington Study Group
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Karen E Anderson, MD, Principal investigator, Georgetown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05268029
- Sponsor's protocol ID
- Making HD Voices Heard
- Status last verified
- Oct 2023
- First submitted
- 27 Dec 2021
- Last updated
- 12 Oct 2023
- 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 12 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Making HD Voices Heard - A Pilot Study on the myHDstory™ Platform
- ClinicalTrials.gov ID
- NCT05268029
- Acronym / sponsor ID
- Making HD Voices Heard
- Conditions
- Huntington Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 698 participants (actual)
- Lead sponsor
- Huntington Study GroupResearch network
- Study start
- 23 Mar 2022 (actual)
- Primary completion
- 11 Oct 2023 (actual)
- Study completion
- 11 Oct 2023 (actual)
- First posted
- 7 Mar 2022 (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 Pilot Study, Making HD Voices Heard, will ask people living with HD to report what they experience and how they function.
Detailed description
The Huntington Study Group (HSG) myHDstory™ Platform is an online, observational research platform that will host the Pilot Study, Making HD Voices Heard. The Pilot Study will ask people living with HD to report what they experience and how they function. Participants will provide self-reported information using their own compatible smartphones, laptops, desktops, or tablets. Participants will be asked to reply to a series of questions, including open-ended questions that will be transcribed by voice (microphone voice-to-text transcription) or keyboard-entered text to record what they experience in their own words.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals who have been diagnosed with Huntington disease.
Key inclusion criteria (9 listed)
- Adults age 18 years and older
- Willing and able to provide informed consent electronically.
- Individuals answering as a participant must self-report they have been diagnosed with HD by a doctor.
- Ability to answer online questions or direct someone else to enter answers for them.
- Ability to ambulate independently and take care of some of his or her personal needs.
Key exclusion criteria (1 listed)
- An individual who does not meet all the inclusion criteria will be excluded from participation in this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The ability to successfully consent and enroll at least 200 HD participants who have early to mid-stage manifest HD.
Time frame: 3 months
Ability to successfully consent and enroll at least 200 manifest HD participants (independent or with help of assistants) within three months as measured by the number of help line calls or emails received requesting technical or clinical support.
Participants' ability to successfully complete online self-reported questionnaires.
Time frame: 3 months
Participants' ability to successfully complete online self-reported questionnaires as measured by the number of completed questionnaires.
Utility and informativeness of data collected.
Time frame: 9 months
Utility and informativeness of capturing, extracting, curating, and analyzing verbatim responses to open-ended questions in the form of the HD-Patient Report of Problems (HD-PROP).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2023.
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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.
Karen E Anderson, MD principal investigator
Georgetown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Huntington Disease, run by Huntington Study Group 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 9 inclusion and 1 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: finished, as of the sponsor's last update on 12 Oct 2023. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The ability to successfully consent and enroll at least 200 HD participants who have early to mid-stage manifest HD. (time frame: 3 months). The study lists 3 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 12 Oct 2023.