Benchmarking Integrated Care for People Living With Huntington's Disease in England (Integrate-HD)

May 18, 2023 updated by: University of Southampton

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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:

  1. Characterise and classify systems/organisations in England involved in HD care in relation to person-centred integrated care from the perspective of users.
  2. Identify areas considered integrated by service users.
  3. Identify areas considered fragmented by service users.
  4. Map care resources used by people living with HD in England.
  5. Identify unmet care needs that need improvement.

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Adults with capacity living in England impacted by Huntington's Disease.

Description

Inclusion Criteria:

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.

Exclusion Criteria:

  • Below 18 years old;
  • Not fluent in English;
  • A person without capacity.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: No intervention administered
Survey only to gather people's experiences, opinions and needs.
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).
Other: No intervention administered
Survey only to gather people's experiences, opinions and needs.
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).
Other: No intervention administered
Survey only to gather people's experiences, opinions and needs.
Informal caregiver
Survey personalised for people caring for another person diagnosed with HD.
Other: No intervention administered
Survey only to gather people's experiences, opinions and needs.
Former informal caregiver
Survey personalised for people that have cared for another person diagnosed with HD in the last 3 years.
Other: No intervention administered
Survey only to gather people's experiences, opinions and needs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
9 months

Collaborators and Investigators

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

Sponsor

University of Southampton

Collaborators

University Hospital Southampton NHS Foundation Trust
National Institute for Health Research, United Kingdom
Central Coast Research Institute for Integrated Care, Australia

Investigators

  • Principal Investigator: Sandra B Pires, MSc, University of Southampton

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)

February 28, 2023

Primary Completion (Anticipated)

November 30, 2023

Study Completion (Anticipated)

February 29, 2024

Study Registration Dates

First Submitted

April 12, 2023

First Submitted That Met QC Criteria

April 12, 2023

First Posted (Actual)

April 25, 2023

Study Record Updates

Last Update Posted (Actual)

May 19, 2023

Last Update Submitted That Met QC Criteria

May 18, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ERGO number: 77725

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

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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