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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • United Kingdom
      • London, United Kingdom, SE5 8AF
        • South London and the Maudsley 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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).
Other: Tool Development meeting
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.
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).
Other: Pilot Test 1 assessment session
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.
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).
Other: Pilot Test 2 assessment session
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Questionnaire
Time Frame: Through study completion, an average of 1 year
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.
Through study completion, an average of 1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
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.
Through study completion, an average of 1 year
The frequency of endorsement per assessment tool item
Time Frame: Through study completion, an average of 1 year
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.
Through study completion, an average of 1 year
Percentage of missing/incomplete items
Time Frame: Through study completion, an average of 1 year
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.
Through study completion, an average of 1 year
Correlation coefficient
Time Frame: Through study completion, an average of 1 year
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
Through study completion, an average of 1 year

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
King's College London

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
South London and Maudsley NHS Foundation Trust

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 28, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 10, 2017

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 12, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 23, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 20, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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