Outcomes That Matter and Questionnaires for Older People With Frailty

NCT ID: NCT06099691

Last Updated: 2024-03-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 15 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-12-18
• Study Completion Date: 2024-03-22

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:

1. What outcomes matter to older adults living with frailty?

2. 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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.

Qualitative Interviews

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Exeter

OTHER

Sponsor Role: collaborator

Royal Devon and Exeter NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Suzy Hope

Role: PRINCIPAL_INVESTIGATOR

Royal Devon and Exeter NHS Foundation Trust

Locations

Royal Devon Hospital

Exeter, Devon, United Kingdom

Countries

United Kingdom

Other Identifiers

329896

Identifier Type: -

Identifier Source: org_study_id