Huntington DiseaseNCT05913154
Impact of Apathy on Caregiving in HD. Version 1
An observational study of Huntington Disease, run by University of East Anglia at 1 site in United Kingdom.
Trial summary
Huntington's disease (HD) can affect motivation. People with HD may not wash often, keep their house clean and tidy, or eating healthy food. This loss of motivation, or apathy, can also affect the way they talk to people and how willing they are to be in social situations. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Huntington Disease
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 26 Apr 2023to Dec 2023
- 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 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Carers of people with Huntington's disease
Who may be able to join
- Participants will be included in the study if:
- They hold significant caring responsibilities for someone with clinically manifest HD
- The person they care for scores above the abnormality cut-off determined for HD on one or more subscale of the Dimensional Apathy Scale - Companion version, or the proposed clinical cut-off for the Apathy Motivational Index - Companion.
- They are 18 years or older and able to give valid, informed consent for study participation.
Who cannot join
- Individuals will be excluded from the study is they:
- Have a lack of spoken English, sufficient to affect their understanding of the interview questions or compromise their ability to express their opinions.
- Did not consent to the interview being recorded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Qualitative Exploration of the Impact of Apathy on the Caregiving Relationship in the Context of Huntington's Disease
Huntington's disease (HD) can affect motivation. People with HD may not wash often, keep their house clean and tidy, or eating healthy food. This loss of motivation, or apathy, can also affect the way they talk to people and how willing they are to be in social situations.
There are thought to be four different subtypes of apathy. These include reduced (1) motivation for planning and organising, (2) emotional reactions, (3) thoughts and actions and (4) social interaction.
Read more
It is clear from talking to patients and their families in clinic that apathy has a big impact. It is often a source of distress for the people around the patient, who are trying to support and care for them. We know from previous research, that having good social support helps people with Huntington's disease to live independently for longer. This research aims to understand the ways in which apathy can impact the levels of burden felt by caregivers of people with HD.
Caregivers will be asked to take part in a single interview. They will be asked questions about caring for someone with apathy. There will also be the opportunity to share their own first-hand experiences. These interviews will be analysed for common themes using framework analysis. Attention will be given to the relationship between burden and the different types of apathy.
Understanding the factors that lead to increased caregiver burden is the first step towards finding way to support caregivers of people with HD.
- Conditions
- Huntington Disease
- Medical subject headings
- Huntington Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive/executive apathy | Not described | |
| Behavioural/inhibition apathy | Not described | |
| Emotional apathy | Not described | |
| Social apathy | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Themes
Synthesised themes generated from the the qualitative interviews with companions
Measured: 1 day (Outcomes will be measured once, at the time of the interview)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start26 Apr 2023
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of East Anglia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Cambridge
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05913154
- Sponsor's protocol ID
- 319976
- Status last verified
- Mar 2023
- First submitted
- 11 May 2023
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Qualitative Exploration of the Impact of Apathy on the Caregiving Relationship in the Context of Huntington's Disease
- ClinicalTrials.gov ID
- NCT05913154
- Acronym / sponsor ID
- 319976
- Conditions
- Huntington Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of East AngliaUniversity, hospital or other
- Collaborators
- University of Cambridge
- Study start
- 26 Apr 2023 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 22 Jun 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.
Huntington's disease (HD) can affect motivation. People with HD may not wash often, keep their house clean and tidy, or eating healthy food. This loss of motivation, or apathy, can also affect the way they talk to people and how willing they are to be in social situations.
There are thought to be four different subtypes of apathy. These include reduced (1) motivation for planning and organising, (2) emotional reactions, (3) thoughts and actions and (4) social interaction.
It is clear from talking to patients and their families in clinic that apathy has a big impact. It is often a source of distress for the people around the patient, who are trying to support and care for them. We know from previous research, that having good social support helps people with Huntington's disease to live independently for longer. This research aims to understand the ways in which apathy can impact the levels of burden felt by caregivers of people with HD.
Caregivers will be asked to take part in a single interview. They will be asked questions about caring for someone with apathy. There will also be the opportunity to share their own first-hand experiences. These interviews will be analysed for common themes using framework analysis. Attention will be given to the relationship between burden and the different types of apathy.
Understanding the factors that lead to increased caregiver burden is the first step towards finding way to support caregivers of people with HD.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cognitive/executive apathy | – | – |
| Behavioural/inhibition apathy | – | – |
| Emotional apathy | – | – |
| Social apathy | – | – |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Carers of people with Huntington's disease
Key inclusion criteria (4 listed)
- They hold significant caring responsibilities for someone with clinically manifest HD
- The person they care for scores above the abnormality cut-off determined for HD on one or more subscale of the Dimensional Apathy Scale - Companion version, or the proposed clinical cut-off for the Apathy Motivational Index - Companion.
- They are 18 years or older and able to give valid, informed consent for study participation.
Key exclusion criteria (3 listed)
- Have a lack of spoken English, sufficient to affect their understanding of the interview questions or compromise their ability to express their opinions.
- Did not consent to the interview being recorded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Themes
Time frame: 1 day (Outcomes will be measured once, at the time of the interview)
Synthesised themes generated from the the qualitative interviews with companions
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
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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.
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 East Anglia 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 4 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 22 Jun 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?
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?
Themes (time frame: 1 day (Outcomes will be measured once, at the time of the interview)). 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 22 Jun 2023.