Outcomes That Matter and Questionnaires for Older People With Frailty

Frailty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06099691
• Other study ID #: 329896
• Status: Completed
• Start date: December 18, 2023
• Est. completion date: March 22, 2024

Study information

• Verified date: March 2024
• Source: Royal Devon and Exeter NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: March 22, 2024
• Est. primary completion date: March 22, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Frailty

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Royal Devon Hospital	Exeter	Devon

Sponsors (2)

Lead Sponsor	Collaborator
Royal Devon and Exeter NHS Foundation Trust	University of Exeter

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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