NCT04503811

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 5, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 7, 2020

Completed
1.1 years until next milestone

Study Start

First participant enrolled

September 15, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 21, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 21, 2022

Completed
Last Updated

March 2, 2022

Status Verified

March 1, 2022

Enrollment Period

5 months

First QC Date

August 5, 2020

Last Update Submit

March 1, 2022

Conditions

Outcome Measures

Primary Outcomes (3)

  • How frail older people understand and experience control in their lives and care

    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.

    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.

    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

Study Arms (2)

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.

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.
  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals Dorset NHS Foundation Trust

Bournemouth, Christchurch, BH7 7DW, United Kingdom

Location

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Caroline Ellis-Hill

    Chief Investigator/Senior Lecturer In Qualitative Research

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2020

First Posted

August 7, 2020

Study Start

September 15, 2021

Primary Completion

February 21, 2022

Study Completion

February 21, 2022

Last Updated

March 2, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL
Time Frame
The data will become available three years after the end of the project.
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.
More information

Locations