Huntington DiseaseNCT03709173
FuRST 2.0 Cognitive Pre-testing - Round 2
An observational study of Huntington Disease, run by CHDI Foundation, Inc. at 4 sites in 2 countries.
Trial summary
The study is a single, cross-sectional cognitive interview of FuRST 2.0, functional rating scale, administered to forty Huntington's Disease Gene Expansion Carriers (HDGECs) and potentially, their companions (the companion's participation is optional in this study). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Huntington Disease
- What is being tested?
- FuRST 2.0
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 52 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 2 Aug 2019to 25 Oct 2019
- 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: An HDGEC: Premanifest and early-manifest HDGEC who is also a participant in Enroll-HD and meets the protocol selection criteria for the HDGEC. HDGEC participants will be recruited from English speaking Enroll-HD sites. A Companion: A person who, in his/her opinion, has sufficient interaction and knowledge of the HDGEC participant's capabilities and daily activities, is acceptable to the HDGEC participant and the site principal investigator (site PI) or site PI's designee and meets the protocol selection criteria for the companion. The companion's participation is optional in this study.
Who may be able to join
- Identified as an active participant in Enroll-HD (participants who have completed their last onsite Enroll-HD visit within approximately 15 months)
- At least 18 years of age
- Fluent in English and had his/her primary education in English
- Able and willing to provide critical feedback (per site PI or site PI's designee discretion)
- Willing and able to provide written informed consent
- Cytosine, Adenine, Guanine (CAG) length ≥ 40
Show all 21Show fewer
- Disease burden score (DBS) ≥ 250
- Diagnostic confidence level (DCL) ≤ 3
- Identified as an active participant in Enroll-HD (participants who have completed their last onsite Enroll-HD visit within approximately 15 months)
- At least 18 years of age
- Fluent in English and had his/her primary education in English
- Able and willing to provide critical feedback (per site PI or site PI's designee discretion)
- Willing and able to provide written informed consent
- CAG length ≥ 36
- DCL= 4
- Total Functional Capacity (TFC) ≥11
- At least 18 years of age
- Fluent in English and had his/her primary education in English
- In his/her opinion, has sufficient interaction and knowledge of the HDGEC participant's capabilities and daily activities
- Is acceptable to the HDGEC participant and the site PI or site PI's designee
- Willing and able to provide written informed consent
Who cannot join
- Significant cognitive or any other impairment sufficient to interfere with study associated tasks as judged by the site PI or the site PI's designee
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 Neurological 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 for a New Functional Rating Scale for Use in Huntington's Disease - Round 2
The study is a single, cross-sectional cognitive interview of FuRST 2.0, functional rating scale, administered to forty Huntington's Disease Gene Expansion Carriers (HDGECs) and potentially, their companions (the companion's participation is optional in this study). The scale will be tested as a patient reported outcome (PRO) in that the information will come directly from the HDGEC participant or the HDGEC participant together with his/her companion through self-report. The purpose is to identify real or potential comprehension or usage problems with scale items, response options, instructions and disclaimer statement, which are all components of the FuRST 2.0 scale. Through a structured cognitive interview with the HDGEC participants or the HDGEC participants together with their companions, followed by qualitative analysis, the final phrasing of the individual scale items, response options, instructions and disclaimer statement for the scale will be generated. Depending on the results of this study, an additional round of cognitive pre-testing may be required in a separate study.
- Conditions
- Huntington Disease
- Being tested
- FuRST 2.0
- 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
Round 2 of cognitive pre-testing for a new functional rating scale
| Study group | Role | What they receive |
|---|---|---|
| Premanifest HDGEC participants | Not described Receives: Behavioral: FuRST 2.0 | |
| Early-manifest HDGEC participants | Not described Receives: Behavioral: FuRST 2.0 | |
| Companions of Premanifest HDGEC | Not described Receives: Behavioral: FuRST 2.0 | |
| Companions of Early-manifest | Not described Receives: Behavioral: FuRST 2.0 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant's 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.
Note: The instructions, items, response options and disclaimer statement are all part of the FuRST 2.0 scale.
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2018
- Study start2 Aug 2019
- Primary completion25 Oct 2019
- Study completion25 Oct 2019
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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 52 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 ), Dr. Nancy LaPelle
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03709173
- Sponsor's protocol ID
- C-000918-3
- Status last verified
- Oct 2019
- First submitted
- 25 Sep 2018
- Last updated
- 29 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FuRST 2.0: Cognitive Pre-testing for a New Functional Rating Scale for Use in Huntington's Disease - Round 2
- ClinicalTrials.gov ID
- NCT03709173
- Acronym / sponsor ID
- C-000918-3
- Conditions
- Huntington Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- CHDI Foundation, Inc.University, hospital or other
- Collaborators
- Dr. Glenn T. Stebbins (Rush University Medical Center ), Dr. Nancy LaPelle
- Study start
- 2 Aug 2019 (actual)
- Primary completion
- 25 Oct 2019 (actual)
- Study completion
- 25 Oct 2019 (actual)
- First posted
- 17 Oct 2018 (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 study is a single, cross-sectional cognitive interview of FuRST 2.0, functional rating scale, administered to forty Huntington's Disease Gene Expansion Carriers (HDGECs) and potentially, their companions (the companion's participation is optional in this study). The scale will be tested as a patient reported outcome (PRO) in that the information will come directly from the HDGEC participant or the HDGEC participant together with his/her companion through self-report. The purpose is to identify real or potential comprehension or usage problems with scale items, response options, instructions and disclaimer statement, which are all components of the FuRST 2.0 scale. Through a structured cognitive interview with the HDGEC participants or the HDGEC participants together with their companions, followed by qualitative analysis, the final phrasing of the individual scale items, response options, instructions and disclaimer statement for the scale will be generated. Depending on the results of this study, an additional round of cognitive pre-testing may be required in a separate study.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Premanifest HDGEC participants | – | Behavioral: FuRST 2.0 |
| Early-manifest HDGEC participants | – | Behavioral: FuRST 2.0 |
| Companions of Premanifest HDGEC | – | Behavioral: FuRST 2.0 |
| Companions of Early-manifest | – | 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
- An HDGEC: Premanifest and early-manifest HDGEC who is also a participant in Enroll-HD and meets the protocol selection criteria for the HDGEC. HDGEC participants will be recruited from English speaking Enroll-HD sites. A Companion: A person who, in his/her opinion, has sufficient interaction and knowledge of the HDGEC participant's capabilities and daily activities, is acceptable to the HDGEC participant and the site principal investigator (site PI) or site PI's designee and meets the protocol selection criteria for the companion. The companion's participation is optional in this study.
Key inclusion criteria (21 listed)
- Identified as an active participant in Enroll-HD (participants who have completed their last onsite Enroll-HD visit within approximately 15 months)
- At least 18 years of age
- Fluent in English and had his/her primary education in English
- Able and willing to provide critical feedback (per site PI or site PI's designee discretion)
- Willing and able to provide written informed consent
Key exclusion criteria (1 listed)
- Significant cognitive or any other impairment sufficient to interfere with study associated tasks as judged by the site PI or the site PI's designee
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 2.0Round 2 of cognitive pre-testing for a new functional rating scale | Behavioural | Companions of Early-manifest, Companions of Premanifest HDGEC, Early-manifest HDGEC participants, Premanifest HDGEC participants |
Primary outcome
Participant's comprehension of the FuRST 2.0 rating scale measured by qualitative analysis.
Time frame: 7 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. Note: The instructions, items, response options and disclaimer statement are all part of the FuRST 2.0 scale.
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 29 Oct 2019.
- 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 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?
The sponsor lists 21 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 29 Oct 2019. 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?
Participant's comprehension of the FuRST 2.0 rating scale measured by qualitative analysis. (time frame: 7 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 29 Oct 2019.