FrailtyNCT06099691
Outcomes That Matter and Questionnaires for Older People With Frailty
An observational study of Frailty, run by Royal Devon and Exeter NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The goal of this qualitative study is to investigate what matters to older people living with frailty, and how this can be measured using questionnaires (Patient Reported Outcome Measures, or "PROMs"). The research questions are: 1. What outcomes matter to older adults living with frailty? 2. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Frailty
- What is being tested?
- Qualitative Interviews
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 15 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 Dec 2023to 22 Mar 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Older people (aged 65 and over) living with frailty.
Who may be able to join
- Over the age of 65
- Indication of frailty in one of the following ways:
- Clinical diagnosis of frailty
- Assessment of at least "4" on the Clinical Frailty Scale by a healthcare professional
- Having mental capacity to consent to participate as defined under the Mental Capacity Act (2005). This will be assessed in the telephone conversation prior to the interview by a researcher who has received Mental Capacity training
- Available to be interviewed by face-to-face interview at the National Institute of Health Research (NIHR) Exeter Clinical Research Facility or as a home visit, or as an online meeting
Who cannot join
- Not able to participate in face-to-face interview or use video call technology
- Not assessed as frail
- Not able to express thoughts and opinions in sufficient depth for analysis, even with facilitation by a relative or carer. This will be assessed in the telephone conversation with the researcher prior to the interview.
- Lacking capacity to consent to participate as defined under the Mental Capacity Act (2005). An individual would be unable to participate if they cannot:
- Understand the information relevant to the decision of participating
- Retain that information
- Use or weigh up that information as part of the process of deciding whether to participate
- Communicate their decision to other people
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigating Outcomes That Matter and the Suitability of PROMs for Older People Living With Frailty
The goal of this qualitative study is to investigate what matters to older people living with frailty, and how this can be measured using questionnaires (Patient Reported Outcome Measures, or "PROMs").
The research questions are:
- What outcomes matter to older adults living with frailty?
- What are participants' perceptions of PROMs that could measure these outcomes?
Our estimated sample will be 15 older adults, approximately 5 people living with mild frailty, 5 living with moderate frailty and 5 living with severe frailty. Participants will take part in one 90-minute interview.
- Conditions
- Frailty
- Being tested
- Qualitative Interviews
- Keywords
- Patient Reported Outcome Measures, Qualitative Research, Frailty, Health Priorities, Quality of Life
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qualitative InterviewsBehavioural
Participants will take part in one 90-minute interview (or two 45-minute interviews if preferred). The interview will have two sections. The first section will include discussion of what matters to participants. The second section will introduce PROMs which may be pertinent to measuring what matters. The participants will be helped to reflect on their relevance and usefulness to them.
| Study group | Role | What they receive |
|---|---|---|
| Older adults with frailty | Participants will be interviewed about what matters to them. They will then give their opinions on questionnaires that aim to measure what matters to them. Receives: Behavioral: Qualitative Interviews |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify outcomes that matter to older people with frailty
Qualitative interviews will be conducted with older people living with frailty to identify what matters to people (e.g. managing pain, functional independence, suitability of medications, social support). This may vary at different severities of frailty.
Measured: 6 months
Investigate perceptions of questionnaires
Qualitative interviews will be conducted with older people living with frailty to investigate participants' perceptions of PROMs (questionnaires) that could measure outcomes that matter to them.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2023
- Study start18 Dec 2023
- Primary completion22 Mar 2024
- Study completion22 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FrailtyStudies 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
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Devon and Exeter NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Exeter
- Responsible party
- Sponsor
- Investigators
- Suzy Hope, Principal investigator, Royal Devon and Exeter NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06099691
- Sponsor's protocol ID
- 329896
- Status last verified
- Mar 2024
- First submitted
- 17 Oct 2023
- Last updated
- 27 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Outcomes That Matter and the Suitability of PROMs for Older People Living With Frailty
- ClinicalTrials.gov ID
- NCT06099691
- Acronym / sponsor ID
- 329896
- Conditions
- Frailty
- Keywords
- Patient Reported Outcome Measures, Qualitative Research, Frailty, Health Priorities, Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Royal Devon and Exeter NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Exeter
- Study start
- 18 Dec 2023 (actual)
- Primary completion
- 22 Mar 2024 (actual)
- Study completion
- 22 Mar 2024 (actual)
- First posted
- 25 Oct 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 goal of this qualitative study is to investigate what matters to older people living with frailty, and how this can be measured using questionnaires (Patient Reported Outcome Measures, or "PROMs").
The research questions are:
- What outcomes matter to older adults living with frailty?
- What are participants' perceptions of PROMs that could measure these outcomes?
Our estimated sample will be 15 older adults, approximately 5 people living with mild frailty, 5 living with moderate frailty and 5 living with severe frailty. Participants will take part in one 90-minute interview.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Older adults with frailty | – | Behavioral: Qualitative InterviewsParticipants will be interviewed about what matters to them. They will then give their opinions on questionnaires that aim to measure what matters to them. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Older people (aged 65 and over) living with frailty.
Key inclusion criteria (6 listed)
- Over the age of 65
- Indication of frailty in one of the following ways:
- Having mental capacity to consent to participate as defined under the Mental Capacity Act (2005). This will be assessed in the telephone conversation prior to the interview by a researcher who has received Mental Capacity training
- Available to be interviewed by face-to-face interview at the National Institute of Health Research (NIHR) Exeter Clinical Research Facility or as a home visit, or as an online meeting
Key exclusion criteria (8 listed)
- Not able to participate in face-to-face interview or use video call technology
- Not assessed as frail
- Not able to express thoughts and opinions in sufficient depth for analysis, even with facilitation by a relative or carer. This will be assessed in the telephone conversation with the researcher prior to the interview.
- Lacking capacity to consent to participate as defined under the Mental Capacity Act (2005). An individual would be unable to participate if they cannot:
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 |
|---|---|---|
| Qualitative InterviewsParticipants will take part in one 90-minute interview (or two 45-minute interviews if preferred). The interview will have two sections. The first section will include discussion of what matters to participants. The second section will introduce PROMs which may be pertinent to measuring what matters. The participants will be helped to reflect on their relevance and usefulness to them. | Behavioural | Older adults with frailty |
Primary outcome
Identify outcomes that matter to older people with frailty
Time frame: 6 months
Qualitative interviews will be conducted with older people living with frailty to identify what matters to people (e.g. managing pain, functional independence, suitability of medications, social support). This may vary at different severities of frailty.
Investigate perceptions of questionnaires
Time frame: 6 months
Qualitative interviews will be conducted with older people living with frailty to investigate participants' perceptions of PROMs (questionnaires) that could measure outcomes that matter to them.
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 27 Mar 2024.
- Individual participant dataSharing planned: No
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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.
Suzy Hope principal investigator
Royal Devon and Exeter NHS Foundation Trust
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 Frailty, run by Royal Devon and Exeter NHS Foundation Trust 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 6 inclusion and 8 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 27 Mar 2024. 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?
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?
Identify outcomes that matter to older people with frailty (time frame: 6 months). The study lists 2 primary outcomes in all. 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 27 Mar 2024.