Clinical trial NCT06099691: Outcomes That Matter and Questionnaires for Older People With Frailty
Official title: Investigating Outcomes That Matter and the Suitability of PROMs for Older People Living With Frailty
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Frailty
Keywords: Patient Reported Outcome Measures
Qualitative Research
Frailty
Health Priorities
Quality of Life
Lead sponsor: Royal Devon and Exeter NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: University of Exeter
First posted: 2023-10-25
Enrollment: 15
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Older people (aged 65 and over) living with frailty.

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.


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

Primary outcomes:
measure: Identify outcomes that matter to older people with frailty
timeFrame: 6 months
measure: Investigate perceptions of questionnaires
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Exeter
country: United Kingdom
facility: Royal Devon Hospital
state: Devon
Study officials:
affiliation: Royal Devon and Exeter NHS Foundation Trust
name: Suzy Hope
role: PRINCIPAL_INVESTIGATOR
References: