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Clinical Trials/NCT03018951
NCT03018951
Completed
Not Applicable

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

King's College London1 site in 1 country40 target enrollmentOctober 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Frailty
Sponsor
King's College London
Enrollment
40
Locations
1
Primary Endpoint
Questionnaire
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
October 2016
End Date
January 2018
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

  • Percentage of missing/incomplete items(Through study completion, an average of 1 year)
  • Intraclass Correlation Coefficient and/or Cohen's Kappa (with 95% confidence intervals)(Through study completion, an average of 1 year)
  • Correlation coefficient(Through study completion, an average of 1 year)
  • The frequency of endorsement per assessment tool item(Through study completion, an average of 1 year)

Study Sites (1)

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