Huntington DiseaseIntegrate-HDNCT05828992
Benchmarking Integrated Care for People Living With Huntington's Disease in England
An observational study of Huntington Disease, run by University of Southampton at 1 site in United Kingdom.
Trial summary
The survey and full study information can be accessed here: https://southampton.qualtrics.com/jfe/form/SV_8iEedDJZy4xaiI6 The goal of this anonymous survey is to benchmark integrated care from the perspective of service users in adults living with Huntington's Disease, including informal caregivers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Huntington Disease
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Feb 2023to 29 Feb 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults with capacity living in England impacted by Huntington's Disease.
Who may be able to join
- Adults with capacity living in England and fluent in English that are:
- A person at risk of HD (where at least one parent is diagnosed with HD, therefore their offspring has 50% chance of developing the disease);
- A person diagnosed with HD symptomatic or asymptomatic (after undergoing gene testing and having a positive result);
- An informal caregiver supporting someone living with HD;
- A former informal caregiver with experience of supporting someone living with HD in the last 3 years.
Who cannot join
- Below 18 years old;
- Not fluent in English;
- A person without capacity.
Trial locations and contacts
1 site in 1 country.
Mari Carmen Portillo, Professor contact
United Kingdom1 site, 1 recruiting
- Recruiting
University of Southampton
Southampton, Hampshire, SO17 1BJ
Sandra B Pires, MSc, s.m.bartolomeu-pires@soton.ac.uk
About this study
Official title: Benchmarking Integrated Care for People Living With Huntington's Disease in England (Integrate-HD Study)
The survey and full study information can be accessed here: https://southampton.qualtrics.com/jfe/form/SV_8iEedDJZy4xaiI6
The goal of this anonymous survey is to benchmark integrated care from the perspective of service users in adults living with Huntington's Disease, including informal caregivers. The main question it aims to answer is: Is standard of care for people living with HD in England person-centred integrated care from the perspective of service users?
Participants will complete a one-time anonymous survey either online or on paper, according to their preference, that takes an average of 20-30 minutes. Participants can take breaks as needed, picking up the survey from where it was paused.
Read the detailed description
Huntington's disease (HD) is a rare brain disease that affects people's coordination, thinking and behaviour. It is a hereditary condition, affecting families across generations. Because its complex, it requires different sectors working together. Different surveys can be found in long term neurological conditions indicating care fragmentation and unmet severe needs, but evidence in HD is sparse.
Two surveys were identified covering people's needs in the UK, dated from 2006 and 2010. When looking for models or approaches tested to improve outcomes for people living with HD, no studies were found. This is an underserved population with complex needs and care gaps that remain unaddressed.
Little is known about to what extent people living with HD are experiencing care coordination between services and sectors in England. Integrate-HD aims to find out what good, joined-up care looks like. The study will explore the views and experiences of people living with HD, to identify the changes needed to improve people's care and quality of life.
Integrate-HD is a national survey to benchmark integrated care from the perspective of people living with HD, including informal caregivers.
The study objectives are to:
- Characterise and classify systems/organisations in England involved in HD care in relation to person-centred integrated care from the perspective of users.
- Identify areas considered integrated by service users.
- Identify areas considered fragmented by service users.
- Map care resources used by people living with HD in England.
- Identify unmet care needs that need improvement.
- Conditions
- Huntington Disease
- Being tested
- No intervention administered
- Keywords
- Integrated care, Huntington's Disease, Caregiver, Person-centred care, Benchmarking, Survey
- Medical subject headings
- Huntington Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention administeredOther
Survey only to gather people's experiences, opinions and needs.
| Study group | Role | What they receive |
|---|---|---|
| Person at risk | Survey personalised for people living at risk of developing Huntington's Disease, meaning they have a parent diagnosed with HD but the person themselves have not undertaken a genetic test. Receives: Other: No intervention administered | |
| Person HD gene positive asymptomatic | Survey personalised for people that tested positive in their predictive genetic test but have not been yet diagnosed with clinical HD (manifest HD). Receives: Other: No intervention administered | |
| Person HD gene positive symptomatic | Survey personalised for people that tested positive in their predictive genetic test and have been diagnosed with clinical HD (manifest HD). Receives: Other: No intervention administered | |
| Informal caregiver | Survey personalised for people caring for another person diagnosed with HD. Receives: Other: No intervention administered | |
| Former informal caregiver | Survey personalised for people that have cared for another person diagnosed with HD in the last 3 years. Receives: Other: No intervention administered |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of integration
Using SPSS (version 27) responses will be analysed to explore the level of integration at specific systems or organizations in England to distinguish between "higher" and "lower" integration levels. The Likert-type scale section of the survey will have a scheme of points attributed to generate a key of integration level per domain.
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 posted25 Apr 2023
- Study start28 Feb 2023
- Primary completion30 Nov 2023 (estimated)
- Study completion29 Feb 2024 (estimated)
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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southampton
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, Central Coast Research Institute for Integrated Care, Australia, University Hospital Southampton NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Sandra B Pires, MSc, Principal investigator, University of Southampton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05828992
- Sponsor's protocol ID
- ERGO number: 77725
- Acronym
- Integrate-HD
- Status last verified
- May 2023
- First submitted
- 12 Apr 2023
- Last updated
- 19 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: During this study all information collected from participants will be kept confidential. The data gathered through surveys is anonymous and will be stored on a secure database using only survey IDs. Any identifiable information, such as email contact provided at the end of the survey (in order to receive updates on the research or show interest in future research) will be stored separately to survey answers. All data will be stored on a password protected university computer/laptop or in a locked filing cabinet in a secure office in the University. This will only be accessible by the research team. The procedures for handling, processing, storing, and destroying data are compliant with the Data Protection Act 2018.
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benchmarking Integrated Care for People Living With Huntington's Disease in England (Integrate-HD Study)
- ClinicalTrials.gov ID
- NCT05828992
- Acronym / sponsor ID
- Integrate-HD / ERGO number: 77725
- Conditions
- Huntington Disease
- Keywords
- Integrated care, Huntington's Disease, Caregiver, Person-centred care, Benchmarking, Survey
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of SouthamptonUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, Central Coast Research Institute for Integrated Care, Australia, University Hospital Southampton NHS Foundation Trust
- Study start
- 28 Feb 2023 (actual)
- Primary completion
- 30 Nov 2023 (estimated)
- Study completion
- 29 Feb 2024 (estimated)
- First posted
- 25 Apr 2023 (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 survey and full study information can be accessed here: https://southampton.qualtrics.com/jfe/form/SV_8iEedDJZy4xaiI6
The goal of this anonymous survey is to benchmark integrated care from the perspective of service users in adults living with Huntington's Disease, including informal caregivers. The main question it aims to answer is: Is standard of care for people living with HD in England person-centred integrated care from the perspective of service users?
Participants will complete a one-time anonymous survey either online or on paper, according to their preference, that takes an average of 20-30 minutes. Participants can take breaks as needed, picking up the survey from where it was paused.
Detailed description
Huntington's disease (HD) is a rare brain disease that affects people's coordination, thinking and behaviour. It is a hereditary condition, affecting families across generations. Because its complex, it requires different sectors working together. Different surveys can be found in long term neurological conditions indicating care fragmentation and unmet severe needs, but evidence in HD is sparse.
Two surveys were identified covering people's needs in the UK, dated from 2006 and 2010. When looking for models or approaches tested to improve outcomes for people living with HD, no studies were found. This is an underserved population with complex needs and care gaps that remain unaddressed.
Little is known about to what extent people living with HD are experiencing care coordination between services and sectors in England. Integrate-HD aims to find out what good, joined-up care looks like. The study will explore the views and experiences of people living with HD, to identify the changes needed to improve people's care and quality of life.
Integrate-HD is a national survey to benchmark integrated care from the perspective of people living with HD, including informal caregivers.
The study objectives are to:
- Characterise and classify systems/organisations in England involved in HD care in relation to person-centred integrated care from the perspective of users.
- Identify areas considered integrated by service users.
- Identify areas considered fragmented by service users.
- Map care resources used by people living with HD in England.
- Identify unmet care needs that need improvement.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Person at risk | – | Other: No intervention administeredSurvey personalised for people living at risk of developing Huntington's Disease, meaning they have a parent diagnosed with HD but the person themselves have not undertaken a genetic test. |
| Person HD gene positive asymptomatic | – | Other: No intervention administeredSurvey personalised for people that tested positive in their predictive genetic test but have not been yet diagnosed with clinical HD (manifest HD). |
| Person HD gene positive symptomatic | – | Other: No intervention administeredSurvey personalised for people that tested positive in their predictive genetic test and have been diagnosed with clinical HD (manifest HD). |
| Informal caregiver | – | Other: No intervention administeredSurvey personalised for people caring for another person diagnosed with HD. |
| Former informal caregiver | – | Other: No intervention administeredSurvey personalised for people that have cared for another person diagnosed with HD in the last 3 years. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with capacity living in England impacted by Huntington's Disease.
Key inclusion criteria (5 listed)
- A person at risk of HD (where at least one parent is diagnosed with HD, therefore their offspring has 50% chance of developing the disease);
- A person diagnosed with HD symptomatic or asymptomatic (after undergoing gene testing and having a positive result);
- An informal caregiver supporting someone living with HD;
- A former informal caregiver with experience of supporting someone living with HD in the last 3 years.
Key exclusion criteria (3 listed)
- Below 18 years old;
- Not fluent in English;
- A person without capacity.
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 |
|---|---|---|
| No intervention administeredSurvey only to gather people's experiences, opinions and needs. | Other | Former informal caregiver, Informal caregiver, Person HD gene positive asymptomatic, Person HD gene positive symptomatic, Person at risk |
Primary outcome
Level of integration
Time frame: 9 months
Using SPSS (version 27) responses will be analysed to explore the level of integration at specific systems or organizations in England to distinguish between "higher" and "lower" integration levels. The Likert-type scale section of the survey will have a scheme of points attributed to generate a key of integration level per domain.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2023.
- Individual participant dataSharing planned: No. During this study all information collected from participants will be kept confidential. The data gathered through surveys is anonymous and will be stored on a secure database using only survey IDs. Any identifiable information, such as email contact provided at the end of the survey (in order to receive updates on the research or show interest in future research) will be stored separately to survey answers. All data will be stored on a password protected university computer/laptop or in a locked filing cabinet in a secure office in the University. This will only be accessible by the research team. The procedures for handling, processing, storing, and destroying data are compliant with the Data Protection Act 2018.
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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.
Mari Carmen Portillo, Professor contact
Sandra B Pires, MSc principal investigator
University of Southampton
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 University of Southampton at 1 site in United Kingdom.
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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 19 May 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 Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sandra B Pires, MSc (07873576074, s.m.bartolomeu-pires@soton.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of integration (time frame: 9 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 19 May 2023.