Making HD Voices Heard

October 11, 2023 updated by: Huntington Study Group

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

698

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Rochester, New York, United States, 14618
        • Huntington Study Group

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Individuals who have been diagnosed with Huntington disease.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months
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.
3 months
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).
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Huntington Study Group

Investigators

  • Principal Investigator: Karen E Anderson, MD, Georgetown University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 23, 2022

Primary Completion (Actual)

October 11, 2023

Study Completion (Actual)

October 11, 2023

Study Registration Dates

First Submitted

December 27, 2021

First Submitted That Met QC Criteria

February 23, 2022

First Posted (Actual)

March 7, 2022

Study Record Updates

Last Update Posted (Actual)

October 12, 2023

Last Update Submitted That Met QC Criteria

October 11, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Making HD Voices Heard

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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