Huntington's DiseaseNCT02881931
FuRST 2.0 Cognitive Pre-Testing
An observational study of Huntington's Disease, run by CHDI Foundation, Inc. at 4 sites in 2 countries.
Trial summary
The FuRST 2.0 scale is being developed as a Patient Reported Outcome (PRO) with information coming directly from the Huntington's Disease Gene Expansion Carrier (HDGEC) and companion through self-report. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Huntington's Disease
- What is being tested?
- FuRST 2.0
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 75 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 28 Feb 2017to 28 Jul 2017
- 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: Participants: Individuals of either gender, equal to or greater than 18 years of age. HDGEC Pre-Manifest and Early-Manifest participants (see inclusion criteria) will be recruited from English speaking Enroll-HD sites. Companions: Available companions for HDGEC Pre-Manifest participants will be encouraged to participate (at least five Pre-Manifest's companions are required). Companions will be identified for HDGEC Early-Manifest participants and asked to participate. Companion's participation for HDGEC Early-Manifest participant is mandatory as specified in the inclusion criteria.
Main criteria for inclusion:
- HDGEC participant must be a participant in Enroll-HD (NCT No.: NCT01574053)
- At least 18 years of age
- Must be fluent in English and had his primary education in English
- Must be willing and able to provide written informed consent
Pre-Manifest HDGECs
Criteria 1-4, and:
- CAG length greater than or equal to 40
- Disease Burden Score greater than or equal to 250 (calculated by the equation: [CAGn-35.5] X age)
- UHDRS Diagnostic Confidence Level (DCL) < 3
- At least five Pre-Manifest HDGEC participants should have a companion who is willing to participate in this study and complete the scale independently.
Early-Manifest (Stage 1\&2) HDGECs
Criteria 1-4, and:
- CAG length greater than or equal to 36
- DCL=4
- UHDRS Total Functional Capacity (TFC) ≥7
- Participants whose companion is willing to participate in this study and complete the scale independently
Main criteria for exclusion:
- Significant cognitive or any other impairment sufficient to interfere with study associated tasks as judged by the study Investigator or the Investigator's designee
- Currently participating in a clinical trial involving an investigational medicinal product
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
Rocky Mountain Movement Disorders Center, P.C.
Englewood, Colorado, 80113
Columbia University
New York, New York, 10032
Hereditary Neurology Disease Centre, Inc.
Wichita, Kansas, 67226
Canada1 site
CENTRE FOR MOVEMENT DISORDERS (Neuropharm Consulting)
Toronto, Ontario, M3B 2S7
About this study
Official title: FuRST 2.0: Cognitive Pre-Testing Study for a New Functional Rating Scale for Use in Huntington's Disease
The FuRST 2.0 scale is being developed as a Patient Reported Outcome (PRO) with information coming directly from the Huntington's Disease Gene Expansion Carrier (HDGEC) and companion through self-report. The purpose of this study is to identify real or potential comprehension or usage problems with questionnaire items or response options. Through a process of structured cognitive de-briefing with HDGEC participants and companions, independently, followed by qualitative analysis, the final phrasing of the individual items and response options for the scale will be generated. Depending on the results of the first round of cognitive pre-testing, additional rounds of cognitive pre-testing may be required.
- Conditions
- Huntington's Disease
- Being tested
- FuRST 2.0
- Keywords
- Huntington's disease, functional rating scale, cognitive pre-testing, patient reported outcome (PRO), HDGEC participant at Pre-Manifest stage, HDGEC participant at Early-Manifest stage, Corresponding HDGEC participant companion
- Medical subject headings
- Huntington Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FuRST 2.0Behavioural
Cognitive Pre-testing of new Functional Rating Scale
| Study group | Role | What they receive |
|---|---|---|
| Pre-Manifest HDGEC Participant | Not described Receives: Behavioral: FuRST 2.0 | |
| Early-Manifest HDGEC Participant | Not described Receives: Behavioral: FuRST 2.0 | |
| Corresponding HDGEC participant Companion | Not described Receives: Behavioral: FuRST 2.0 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants' comprehension of the FuRST 2.0 rating scale measured by qualitative analysis
The primary assessment will use qualitative analysis of the cognitive interview to determine the usability of the FuRST 2.0 scale in the HD population.
Measured: 8 months
Secondary outcomes (1)
The difference between the ratings of the HDGEC participants and the companions measured by the FuRST 2.0 rating scale
The secondary outcome measure will be evaluated using the Kolmogorov-Smirnov test
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2016 (estimated)
- Study start28 Feb 2017
- Primary completion28 Jul 2017
- Study completion28 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Huntington's 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
- Other
- Time perspective
- Prospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHDI Foundation, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Dr. Glenn T. Stebbins (Rush University Medical Center ), The University of Texas Health Science Center, Houston, Nancy LaPelle
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02881931
- Sponsor's protocol ID
- C-000316
- Status last verified
- Aug 2017
- First submitted
- 12 Aug 2016
- Last updated
- 8 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FuRST 2.0: Cognitive Pre-Testing Study for a New Functional Rating Scale for Use in Huntington's Disease
- ClinicalTrials.gov ID
- NCT02881931
- Acronym / sponsor ID
- C-000316
- Conditions
- Huntington's Disease
- Keywords
- Huntington's disease, functional rating scale, cognitive pre-testing, patient reported outcome (PRO), HDGEC participant at Pre-Manifest stage, HDGEC participant at Early-Manifest stage, Corresponding HDGEC participant companion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- CHDI Foundation, Inc.University, hospital or other
- Collaborators
- Dr. Glenn T. Stebbins (Rush University Medical Center ), The University of Texas Health Science Center, Houston, Nancy LaPelle
- Study start
- 28 Feb 2017 (actual)
- Primary completion
- 28 Jul 2017 (actual)
- Study completion
- 28 Jul 2017 (actual)
- First posted
- 29 Aug 2016 (estimated)
- 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 FuRST 2.0 scale is being developed as a Patient Reported Outcome (PRO) with information coming directly from the Huntington's Disease Gene Expansion Carrier (HDGEC) and companion through self-report. The purpose of this study is to identify real or potential comprehension or usage problems with questionnaire items or response options. Through a process of structured cognitive de-briefing with HDGEC participants and companions, independently, followed by qualitative analysis, the final phrasing of the individual items and response options for the scale will be generated. Depending on the results of the first round of cognitive pre-testing, additional rounds of cognitive pre-testing may be required.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pre-Manifest HDGEC Participant | – | Behavioral: FuRST 2.0 |
| Early-Manifest HDGEC Participant | – | Behavioral: FuRST 2.0 |
| Corresponding HDGEC participant Companion | – | Behavioral: FuRST 2.0 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants: Individuals of either gender, equal to or greater than 18 years of age. HDGEC Pre-Manifest and Early-Manifest participants (see inclusion criteria) will be recruited from English speaking Enroll-HD sites. Companions: Available companions for HDGEC Pre-Manifest participants will be encouraged to participate (at least five Pre-Manifest's companions are required). Companions will be identified for HDGEC Early-Manifest participants and asked to participate. Companion's participation for HDGEC Early-Manifest participant is mandatory as specified in the inclusion criteria.
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 |
|---|---|---|
| FuRST 2.0Cognitive Pre-testing of new Functional Rating Scale | Behavioural | Corresponding HDGEC participant Companion, Early-Manifest HDGEC Participant, Pre-Manifest HDGEC Participant |
Primary outcome
Participants' comprehension of the FuRST 2.0 rating scale measured by qualitative analysis
Time frame: 8 months
The primary assessment will use qualitative analysis of the cognitive interview to determine the usability of the FuRST 2.0 scale in the HD population.
1 secondary outcome
The difference between the ratings of the HDGEC participants and the companions measured by the FuRST 2.0 rating scale
Time frame: 8 months
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 8 Aug 2017.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Huntington's Disease, run by CHDI Foundation, Inc. at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 8 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Canada. 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?
Participants' comprehension of the FuRST 2.0 rating scale measured by qualitative analysis (time frame: 8 months). 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 8 Aug 2017.