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Assessing Frailty in Older Adults With Functional Mental Illness

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2016 by King's College London
Sponsor:
Collaborator:
South London and Maudsley NHS Foundation Trust
Information provided by (Responsible Party):
King's College London
ClinicalTrials.gov Identifier:
NCT03018951
First received: September 28, 2016
Last updated: January 13, 2017
Last verified: September 2016
  Purpose
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.

Condition Intervention
Frailty
Mental Illness
Other: Tool Development meeting
Other: Pilot Test 1 assessment session
Other: Pilot Test 2 assessment session

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Developing a Tool to Assess Frailty in Older Adults With a Diagnosis of Functional Mental Illness; Tool Development and Pilot Testing.

Resource links provided by NLM:


Further study details as provided by King's College London:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.

  • 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.

  • 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.

  • 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


Estimated Enrollment: 65
Study Start Date: October 2016
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03018951

Contacts
Contact: Jennifer L Sutton, MSc Occupational therapy +44 (0)20 7848 0508 jennifer.1.sutton@kcl.ac.uk
Contact: Robert Howard, Professor MD +44 (0)20 7848 0508 robert.howard@ucl.ac.uk

Locations
United Kingdom
South London and the Maudsley NHS Foundation Trust Recruiting
London, United Kingdom, SE5 8AF
Contact: jennifer liebscher    020 7848 0251    jennifer.liebscher@kcl.ac.uk   
Sponsors and Collaborators
King's College London
South London and Maudsley NHS Foundation Trust
Investigators
Principal Investigator: Robert Howard, Professor MD King's College London
  More Information

Publications:
Responsible Party: King's College London
ClinicalTrials.gov Identifier: NCT03018951     History of Changes
Other Study ID Numbers: REC REF:16 LO 1506
196557 ( Other Identifier: IRAS Project ID )
Study First Received: September 28, 2016
Last Updated: January 13, 2017
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by King's College London:
frailty, assessement

Additional relevant MeSH terms:
Mental Disorders

ClinicalTrials.gov processed this record on April 24, 2017