Outcomes That Matter and Questionnaires for Older People With Frailty

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:

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.

Study Overview

• Status: Completed
• Conditions: Frailty
• Intervention / Treatment: Behavioral: Qualitative Interviews

• Study Type: Observational
• Enrollment (Actual): 15

Contacts and Locations

Study Locations

• United Kingdom
  • Devon
    • Exeter, Devon, United Kingdom, EX2 5DW
      • Royal Devon Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Royal Devon and Exeter NHS Foundation Trust
• Collaborators: University of Exeter
• Investigators: Principal Investigator: Suzy Hope, Royal Devon University Healthcare NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2023
• Primary Completion (Actual): March 22, 2024
• Study Completion (Actual): March 22, 2024

Study Registration Dates

• First Submitted: October 17, 2023
• First Submitted That Met QC Criteria: October 17, 2023
• First Posted (Actual): October 25, 2023

Study Record Updates

• Last Update Posted (Actual): March 27, 2024
• Last Update Submitted That Met QC Criteria: March 26, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Quality of Life; Frailty; Patient Reported Outcome Measures; Qualitative Research; Health Priorities
• Additional Relevant MeSH Terms: Pathologic Processes; Frailty
• Other Study ID Numbers: 329896

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No