Making HD Voices Heard

Huntington Disease Clinical Trial

Official title:

Making HD Voices Heard - A Pilot Study on the myHDstory™ Platform

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05268029
• Other study ID #: Making HD Voices Heard
• Status: Completed
• Start date: March 23, 2022
• Est. completion date: October 11, 2023

Study information

• Verified date: October 2023
• Source: Huntington Study Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The Pilot Study, Making HD Voices Heard, will ask people living with HD to report what they experience and how they function.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 698
• Est. completion date: October 11, 2023
• Est. primary completion date: October 11, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.
• 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 Exclusion Criteria: An individual who does not meet all the inclusion criteria will be excluded from participation in this study.

Related Conditions & MeSH terms

• Huntington Disease

Locations

Country	Name	City	State
United States	Huntington Study Group	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
Huntington Study Group

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 months
Primary	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.	3 months
Primary	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).	9 months