Outcomes That Matter and Questionnaires for Older People With Frailty

NCT06099691 | Completed

• 1 other identifier: 329896
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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. 1.What outcomes matter to older adults living with frailty?
2. 2.What are participants' perceptions of PROMs that could measure these outcomes?

Conditions

Frailty

Keywords

Patient Reported Outcome Measures; Qualitative Research; Frailty; Health Priorities; Quality of Life

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  6 months

Study Arms (1)

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

Interventions

Qualitative Interviews 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.

Older adults with frailty

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Older people (aged 65 and over) living with frailty.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Royal Devon and Exeter NHS Foundation Trust: lead
• University of Exeter: collaborator

Study Sites (1)

Royal Devon Hospital

Exeter, Devon, EX2 5DW, United Kingdom

Location

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Suzy Hope

  Royal Devon and Exeter NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2023
• First Posted: October 25, 2023
• Study Start: December 18, 2023
• Primary Completion: March 22, 2024
• Study Completion: March 22, 2024
• Last Updated: March 27, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)