Skip to main content
OpenTrials
Completed

NCT Number: NCT03018951

Assessing Frailty in Older Adults With Functional Mental Illness

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Frailty Mental Disorders Mental Illness Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

South London and the Maudsley NHS Foundation Trust

London, SE5 8AF, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tool Development meeting

Other

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 assessment session

Other

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 assessment session

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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

Sponsors and collaborators

Lead sponsor

King's College London

Other

Collaborators

  • South London and Maudsley NHS Foundation Trust

Registry information

Official study title

Developing a Tool to Assess Frailty in Older Adults With a Diagnosis of Functional Mental Illness; Tool Development and Pilot Testing.

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jan 12, 2017
Registry last updated
Jan 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.