Clinical trial NCT03018951: Assessing Frailty in Older Adults With Functional Mental Illness
Official title: Developing a Tool to Assess Frailty in Older Adults With a Diagnosis of Functional Mental Illness; Tool Development and Pilot Testing.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Frailty
Mental Illness
Keywords: frailty, assessement
Lead sponsor: King's College London
Sponsor class: OTHER
Collaborators: name: South London and Maudsley NHS Foundation Trust
First posted: 2017-01-12
Enrollment: 40
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.


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.

Primary outcomes:
measure: Questionnaire
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Intraclass Correlation Coefficient and/or Cohen's Kappa (with 95% confidence intervals)
timeFrame: Through study completion, an average of 1 year
measure: The frequency of endorsement per assessment tool item
timeFrame: Through study completion, an average of 1 year
measure: Percentage of missing/incomplete items
timeFrame: Through study completion, an average of 1 year
measure: Correlation coefficient
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: South London and the Maudsley NHS Foundation Trust
Study officials:
affiliation: King's College London
name: Robert Howard, Professor MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.