- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03018951
Assessing Frailty in Older Adults With Functional Mental Illness
January 20, 2020 updated by: King's College London
Developing a Tool to Assess Frailty in Older Adults With a Diagnosis of Functional Mental Illness; Tool Development and Pilot Testing.
The purpose of this study is the development of, and two stages of pilot testing of, a tool designed to assess frailty in older adults with a diagnosis of a functional mental illness.
During the tool's development stage, participants' input, ideas and feedback will be sought to inform the tool's design.
In the first pilot test the comprehensibility, acceptability and feasibility of the tool will be established.
The tool will be amended based on information gained in the first pilot test.
In the second pilot test the comprehensibility, acceptability and feasibility of the revised tool will be established.
Reliability of the tool will be explored and preliminary examinations of both the interpretability and construct validity of the tool will be completed.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
40
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
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London, United Kingdom, SE5 8AF
- South London and the Maudsley NHS Foundation Trust
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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
Mental Health care of Older Adult community and inpatient services, South London and the Maudsley NHS Foundation Trust.
Description
Inclusion Criteria:
- Aged ≥65 years
- Diagnosis of one of the following functional mental illnesses; depression, anxiety, bipolar affective disorder, schizophrenia.
- Currently in receipt of mental health services under The Care Programme Approach (CPA).
- Presence of ≥2 of the following frailty indicators: Aged ≥75 years old, prescribed ≥5 medications, a history of ≥1 fall/s in the 6-month period prior to assessment, admission to hospital in the 6-month period prior to assessment. In receipt of weekly support for Activities of Daily Living (ADL) tasks, In receipt of daily support for Instrumental Activities of Daily Living (IADL) tasks, ≥2 chronic physical health conditions.
- Fluent in English language.
- Able to provide informed consent to engage in the study.
- Able to tolerate the mental and physical demands of the study
Exclusion Criteria:
- A diagnosis of a neurodegenerative condition (e.g. mild cognitive impairment or dementia), neurological condition (e.g. stroke, Parkinson's disease) or head injury (where a loss of consciousness greater than 10 minutes is reported/recorded).
- The presence of a severe sensory impairment (e.g. registered blind or deaf).
- Presence of a developmental intellectual disability.
- Current alcohol/substance abuse or dependence.
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 |
Intervention / Treatment |
---|---|
Tool Development Stage
Older adults aged ≥65 years with a diagnosis of functional mental illness who show some signs of potentially being frail (presence of ≥2 of the following frailty indicators: Aged ≥75 years old, prescribed ≥5 medications, a history of ≥1 fall/s in the 6-month period prior to assessment, admission to hospital in the 6-month period prior to assessment.
In receipt of weekly support for Activities of Daily Living (ADL) tasks, In receipt of daily support for Instrumental Activities of Daily Living (IADL) tasks, ≥2 chronic physical health conditions).
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Consenting participants will be invited to attend up to four meetings concerning the design of the specialist tool to assess frailty in older adults with a diagnosis of functional mental illness.
The meetings will be small with up to three participants and the Chief Investigator present.
The Chief Investigator will present the group with plans and ideas for the proposed assessment tool and facilitate discussions relating to these ideas.
Participants will be encouraged to share their opinions and any ideas they may have.
The chief investigator will take written meeting minutes during each session, which will be checked and agreed on by all meeting attendees.
Each meeting will last no more than 90 minutes.
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Pilot Test 1
Older adults aged ≥65 years with a diagnosis of functional mental illness who show some signs of potentially being frail (presence of ≥2 of the following frailty indicators: Aged ≥75 years old, prescribed ≥5 medications, a history of ≥1 fall/s in the 6-month period prior to assessment, admission to hospital in the 6-month period prior to assessment.
In receipt of weekly support for Activities of Daily Living (ADL) tasks, In receipt of daily support for Instrumental Activities of Daily Living (IADL) tasks, ≥2 chronic physical health conditions).
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Consenting participants will engage in a one off assessment session where the newly devised specialist tool to assess frailty in older adults with a diagnosis of functional mental illness will be administered.
Participants will be asked a series of verbal questions related to frailty indicators and asked to engage in basic observational tests of walking speed and both static and dynamic balance.
Qualitative data will be gathered from the participant to establish the comprehensibility, relevance, acceptability and feasibility of the tool via a questionnaire that includes both Likert scales and open ended questions.
To assess the comprehensibility of the tool's questions each participant will also be asked to rephrase a subset of the tools questions.
The duration of the assessment session will be 90 minutes maximum.
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Pilot Test 2
Older adults aged ≥65 years with a diagnosis of functional mental illness who show some signs of potentially being frail (presence of ≥2 of the following frailty indicators: Aged ≥75 years old, prescribed ≥5 medications, a history of ≥1 fall/s in the 6-month period prior to assessment, admission to hospital in the 6-month period prior to assessment.
In receipt of weekly support for Activities of Daily Living (ADL) tasks, In receipt of daily support for Instrumental Activities of Daily Living (IADL) tasks, ≥2 chronic physical health conditions).
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Consenting participants will engage in a one off assessment session where the revised specialist tool to assess frailty in older adults with a diagnosis of functional mental illness will be administered.
The administration of the tool will follow the same process as in pilot test 1.
Participants will then be asked to complete a further self-rated frailty assessment tool: the Tilburg Frailty Indicator.
Again, following the administration of the tools, qualitative data will be gathered from the participant to establish the comprehensibility, relevance, acceptability and feasibility of the revised tool as per the methods in pilot test 1.
The tool will be scored by a study researcher and the study's chief investigator at the same time to assess inter-rater reliability.
The duration of the assessment session will be 90 minutes maximum.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Questionnaire
Time Frame: Through study completion, an average of 1 year
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The primary outcome measure for this study is a questionnaire containing both likert scales and open ended questions designed to obtain feedback from both the participant and rater regarding the comprehensibility, acceptability and feasibility of the newly devised assessment tool designed to assess frailty in older adults with a diagnosis of functional mental illness.
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Through study completion, an average of 1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intraclass Correlation Coefficient and/or Cohen's Kappa (with 95% confidence intervals)
Time Frame: Through study completion, an average of 1 year
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The Intraclass Correlation Coefficient and/or Cohen's Kappa (with 95% confidence intervals) of the repeated measures of the revised tool designed to assess frailty in older adults with a diagnosis of functional mental illness.
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Through study completion, an average of 1 year
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The frequency of endorsement per assessment tool item
Time Frame: Through study completion, an average of 1 year
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The endorsement frequency for item's of the newly devised tool to assess frailty in older adult populations with a diagnosis of functional mental illness response.
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Through study completion, an average of 1 year
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Percentage of missing/incomplete items
Time Frame: Through study completion, an average of 1 year
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The percentage of missing/incomplete items of the newly devised tool to assess frailty in older adult populations with a diagnosis of functional mental illness.
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Through study completion, an average of 1 year
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Correlation coefficient
Time Frame: Through study completion, an average of 1 year
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Correlation coefficients between scores of the revised tool designed to assess frailty in older adult with a diagnosis of functional mental illness tool and the Tilburg Frailty Indicator
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Through study completion, an average of 1 year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Robert Howard, Professor MD, King's College London
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Sutton JL, Gould RL, Daley S, Coulson MC, Ward EV, Butler AM, Nunn SP, Howard RJ. Psychometric properties of multicomponent tools designed to assess frailty in older adults: A systematic review. BMC Geriatr. 2016 Feb 29;16:55. doi: 10.1186/s12877-016-0225-2.
- Sutton JL, Gould RL, Coulson MC, Ward EV, Butler AM, Smith M, Lavelle G, Rosa A, Langridge M, Howard RJ. Multicomponent Frailty Assessment Tools for Older People with Psychiatric Disorders: A Systematic Review. J Am Geriatr Soc. 2019 May;67(5):1085-1095. doi: 10.1111/jgs.15710. Epub 2018 Dec 27.
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
October 1, 2016
Primary Completion (Actual)
January 1, 2018
Study Completion (Actual)
January 1, 2018
Study Registration Dates
First Submitted
September 28, 2016
First Submitted That Met QC Criteria
January 10, 2017
First Posted (Estimate)
January 12, 2017
Study Record Updates
Last Update Posted (Actual)
January 23, 2020
Last Update Submitted That Met QC Criteria
January 20, 2020
Last Verified
August 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC REF:16 LO 1506
- 196557 (Other Identifier: IRAS Project ID)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.
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