Outcomes That Matter and Questionnaires for Older People With Frailty

Completed

• Conditions: Frailty
• Interventions: Behavioral: Qualitative Interviews

• Registration Number: NCT06099691
• Lead Sponsor: Royal Devon and Exeter NHS Foundation Trust

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-17
• Study First Submitted QC: 2023-10-17
• Study First Posted: 2023-10-25
• Study Start: 2023-12-18
• Status Verified: 2024-03
• Primary Completion: 2024-03-22
• Study Completion: 2024-03-22
• Last Update Submitted: 2024-03-26
• Last Update Posted: 2024-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Older adults with frailty	Qualitative Interviews	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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Royal Devon Hospital; 🇬🇧 Exeter, Devon, United Kingdom