Outcomes That Matter and Questionnaires for Older People 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.

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Key information

Conditions

Frailty Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Royal Devon Hospital

Exeter, Devon, EX2 5DW, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

Identify outcomes that matter to older people with frailty

Time frame: 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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Royal Devon and Exeter NHS Foundation Trust

Other

Collaborators

University of Exeter

Registry information

Official study title

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

Important dates

Study start: 2023
Primary completion: 2024
Study completion: 2024
First posted: Oct 25, 2023
Registry last updated: Mar 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed