Outcomes That Matter and Questionnaires for Older People With Frailty

Sponsor

Royal Devon and Exeter NHS Foundation Trust (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06099691

Collaborator

University of Exeter (Other)

Enrollment

Location

Anticipated Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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:

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.

Condition or Disease	Intervention/Treatment	Phase
Frailty	Behavioral: Qualitative Interviews

Study Design

Study Type:

Observational

Anticipated Enrollment :

15 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

Investigating Outcomes That Matter and the Suitability of PROMs for Older People Living With Frailty

Anticipated Study Start Date :

Oct 30, 2023

Anticipated Primary Completion Date :

May 1, 2024

Anticipated Study Completion Date :

May 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
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.	Behavioral: Qualitative Interviews 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.

Arm

Intervention/Treatment

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.

Behavioral: Qualitative Interviews

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.

Outcome Measures

Primary Outcome Measures

Identify outcomes that matter to older people with frailty [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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