Sense of Control in Frail Older Persons (CONtrol)

March 1, 2022 updated by: Bournemouth University

Exploring the Lived Experience of Control and Wellbeing of Older Persons Diagnosed With Frailty Within the Care Service Provision in Southern England

The proposed study seeks to explore the lived experience of control and wellbeing of older people diagnosed with frailty within the care service provision in southern England.

In the study, the researcher will talk with older people diagnosed with frailty and the professionals that provide care to them. The researcher is interested in understanding participants' experiences of a sense of control and how health and social care services affect this experience.

Although research has shown that rehabilitation can be effective in maintaining physical activity often frail older people do not wish to take up the rehabilitation services provided. Research in this area has been dominated by health care professionals' views about frailty and how services should be provided. Services could be improved by learning from the first-hand experiences of older people living with frailty and what they feel increases their level of control and wellbeing within their service use. The factors which increase their sense of control and wellbeing can then be built into future service development, inform care policies, and provide new understanding for future research to develop services which are more attractive and relevant for older frail people.

All persons aged 65 years and over, with a diagnosis of frailty will be eligible to take part in one to one interviews with the researcher. From the interviews principles underpinning good practice which enhances the sense of control and wellbeing in older people's lives and within the services received will be identified. These will be shared with professional care providers including nurses, doctors, and physiotherapists who routinely work with frail older people to gain insights into how these principles can be integrated into practice and developed in policy and future service development. The findings will, therefore, help to develop services which ensure that they are supportive and increase a sense of control in life rather than getting in the way of this.

The study is expected to last 12 months and up to 30 participants (20 older people and 10 Hospital staff) will be recruited to take part in the study.

Study Overview

Status

Completed

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Christchurch
      • Bournemouth, Christchurch, United Kingdom, BH7 7DW
        • University Hospitals Dorset NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study will focus on frail older people and Day Hospital staff that provide care to them.

Description

Inclusion Criteria:

Phase one inclusion criteria (frail older people) The pre-selected inclusion criteria for this category of participants include;

  • older people (aged 65 years and over);
  • individuals diagnosed with frailty and receiving (part of their) care services at the Day Hospital;
  • the capacity to give free and fully informed consent;
  • ability to use the English language, as well as judgement by the clinical staff and/or nominated manager that the potential participant can take part in an in-depth interview.

Phase two inclusion criteria (Hospital staff)

  • The study will include staff that routinely work with frail older people at the Day Hospital including nurses (registered and unregistered), doctors, physiotherapists, occupational therapists and therapy assistants that can give free and fully informed consent.
  • Furthermore, the study will include both part-time and full-time staff with a minimum of six months of work experience with frail older people.

Exclusion Criteria:

Phase one exclusion criteria

The exclusion criteria, on the other hand, will include:

  • people who cannot communicate in English;
  • and individuals who are acutely medically unwell.

Phase two exclusion criteria

The second phase of the study will, on the other hand, exclude:

• all staff who do not have routine direct contact with patients' care, for example, the senior managers.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Frail Older People
The first phase of the data collection process will include one to one interviews with up to twenty (20) frail older people. The pre-selected inclusion criteria for this category of participants include; older people (aged 65 years and over); individuals diagnosed with frailty and receiving (part of their) care services at the Day Hospital; the capacity to give free and fully informed consent; ability to use the English language, as well as judgement by the clinical staff and/or nominated manager that the potential participant can take part in an in-depth interview.
Day Hospital Staff
The second phase of the data collection process will entail one to one interviews with up to ten (10) Staff at the Day Hospital. The study will include staff that routinely work with frail older people at the Day Hospital including nurses (registered and unregistered), doctors, physiotherapists, occupational therapists and therapy assistants that can give free and fully informed consent. Furthermore, the study will include both part-time and full-time staff with a minimum of six months of work experience with frail older people.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
How frail older people understand and experience control in their lives and care
Time Frame: Up to one and a half hours
The study will highlight frail older people's experiences, opinions and viewpoints on their sense of control in their lives and care processes and how this impacts on their dignity and well-being.
Up to one and a half hours
How frail older peoples' experiences can be used to shape and enhance care design and delivery.
Time Frame: Up to one and a half hours
The study will aslo highlight how health and social care practices can draw from older people's experiences to inform the design and delivery of care services.
Up to one and a half hours
How professional care providers can integrate into care practice principles that enhance service users' sense of control and well-being.
Time Frame: Up to one hour
The study will help professional care providers working with older people to develop services which ensure that they are supportive and increase a sense of control in life rather than getting in the way of this.
Up to one hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Caroline Ellis-Hill, Chief Investigator/Senior Lecturer In Qualitative Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2021

Primary Completion (Actual)

February 21, 2022

Study Completion (Actual)

February 21, 2022

Study Registration Dates

First Submitted

August 5, 2020

First Submitted That Met QC Criteria

August 5, 2020

First Posted (Actual)

August 7, 2020

Study Record Updates

Last Update Posted (Actual)

March 2, 2022

Last Update Submitted That Met QC Criteria

March 1, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AN282540

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The researcher will ensure that the Data is made open and accessible to other researchers in line with the provisions of the InnovateDignity Project Data Management Plan and the Bournemouth University Research Data Policy.

Once the study has ended, anonymised data from the project will be deposited in the 'UK Data Archive' in Qualibank for example and QuDEX as a way of ensuring that the data are easily accessible to other researchers in the specific field of study and/or social scientists in related fields such as health care and policy research. However, there will be an embargo of up to 3 years on publications, after which data will be made available and accessible via the UK Data Archive.

The data will be secured in line with the UK Data Archive policies and at the end of the project and the three-year embargo, researchers seeking access to the data will have to go through the UK Data Service access processes.

IPD Sharing Time Frame

The data will become available three years after the end of the project.

IPD Sharing Access Criteria

The data will be secured in line with the UK Data Archive policies and at the end of the project and the three-year embargo, researchers seeking access to the data will have to go through the UK Data Service access processes.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Frailty

Subscribe