NCT05828992

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 28, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 12, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 25, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 29, 2024

Completed
Last Updated

May 19, 2023

Status Verified

May 1, 2023

Enrollment Period

9 months

First QC Date

April 12, 2023

Last Update Submit

May 18, 2023

Conditions

Keywords

Integrated careHuntington's DiseaseCaregiverPerson-centred careBenchmarkingSurvey

Outcome Measures

Primary Outcomes (1)

  • 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.

    9 months

Study Arms (5)

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

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

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

Informal caregiver

Survey personalised for people caring for another person diagnosed with HD.

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.

Other: No intervention administered

Interventions

Survey only to gather people's experiences, opinions and needs.

Former informal caregiverInformal caregiverPerson HD gene positive asymptomaticPerson HD gene positive symptomaticPerson at risk

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Southampton

Southampton, Hampshire, SO17 1BJ, United Kingdom

RECRUITING

MeSH Terms

Conditions

Huntington Disease

Condition Hierarchy (Ancestors)

Basal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesDementiaChoreaDyskinesiasMovement DisordersHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Sandra B Pires, MSc

    University of Southampton

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mari Carmen Portillo, Professor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 12, 2023

First Posted

April 25, 2023

Study Start

February 28, 2023

Primary Completion

November 30, 2023

Study Completion

February 29, 2024

Last Updated

May 19, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

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.

Locations