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Completed

NCT Number: NCT03591055

Frailty Assessment and Treatment Strategies in the Elderly at Risk of Functional Decline in the Community

This study aims to design a patient -centered program to prevent or delay frailty , functional decline and adverse events, and evaluates the effectiveness of the program with a randomized clinical trial.

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Key information

Conditions

Frail Elderly Syndrome

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IDIAP JGol

Barcelona, 08007, Spain

About this study

Objective: To design and evaluate the implementation and impact of a multimodal intervention focused on elderly patients living in the community in preventing or delaying frailty, functional decline and risk of institutionalization, hospitalization and death.

Design: Study in two phases: a qualitative study to develop the intervention and a randomized clinical trial with parallel arms and control group.

Intervention: Participants in the control group will receive the usual standard care and regular referrals. Patients in the intervention group will be first derived to a nurse case manager for initial application of a comprehensive geriatric assessment (CGA). Then patient-centered interventions will be prescribed, according to the different target areas identified in the geriatric assessment, along with medication review, aerobics exercise plan and memory workshops following the model adapted in Phase I.

After 3 and 18 months, measures of functional and cognitive performance, quality of life, frailty, adverse outcomes (institutionalization, hospitalization, death) and health care costs will be collected.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Positive screen in the accumulation of deficits electronic frailty index
  • Positive screen with Gerontopole screening tool and/or RISC tool

Exclusion criteria

  • Living in an institution
  • Advanced conditions with short life expectancy
  • Severe disability
  • Severe Dementia

Treatment and study plan

CGA, medication review, exercise and cognitive stimulation

Other

Comprehensive geriatric assessment. Patient-centered interventions according to the different target areas identified in the geriatric assessment. Medication review. Groupal Exercise plan and memory workshops.

Primary outcomes

  1. Change from Baseline in Short Physical Performance Battery (SPPB) at 3 and 18 months

    Time frame: 0, 3, 18 months

    The Short Physical Performance Battery (SPPB) is a standardised assessment tool of lower limb function, testing 3 dimensions: standing balance, walking speed, and chair stands. Each component is scored between 0-4, total score from 0 (poor performance) to 12 (best performance).

  2. Change from Baseline in the Quick Mild Cognitive Impairment Screen (Qmci-S) at 3 and 18 months

    Time frame: 0, 3, 18 months

    The Quick Mild Cognitive Impairment (Qmci) screen is a multi-purpose, short cognitive screening instrument designed to differentiate between normal cognitive function, subjective cognitive disorders, mild cognitive impairment (MCI) and early dementia and to measure change over time.

  3. Change from Baseline in Health Related Quality of Life (EuroQol 5D) at 3 and 18 months

    Time frame: 0, 3, 18 months

    EuroQol 5D EQ-5D is a standardised measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal.

Secondary outcomes

  1. Change from Baseline in Functional Capacity at 3 and 18 months

    Time frame: 0, 3, 18 months

    Activities of daily living: Barthel Index and Lawton&Brody Index

  2. Change from Baseline in the Risk Instrument for Screening in the Community (RISC) at 3 and 18 months

    Time frame: 0, 3, 18 months

    Risk Instrument for Screening in the Community is a validated short (2-5 min), global subjective assessment of risk created to identify patients' 1-year risk of three outcomes: institutionalization, hospitalization and death.

  3. Change from Baseline in Clinical Frailty Scale (CFS) at 3 and 18 months

    Time frame: 0,3 18 months

    The clinical frailty scale is a 9 points measure of frailty based on clinical judgement.

  4. Change from Baseline in the Gerontopole Frailty Screening Tool (GFST) at 3 and 18 months

    Time frame: 0,3,18 months

    Gerontopole Frailty Screening Tool is a questionnaire aimed to measure general signs and/or symptoms potentially indicating the presence of an underlying frailty. These questions largely mirror the criteria that are commonly used to operationalize the frailty status.

Other outcomes

  1. Number of Participants Institutionalized during follow-up, at 18 months

    Time frame: 18 months

    Admission to long-term care {nursing home}

  2. Number of Participants Hospitalized during follow-up, at 18 months

    Time frame: 18 months

    Hospitalization including prolonged admission or readmission

  3. Number of Participants who die during follow-up, at 18 months

    Time frame: 18 months

    Death

  4. Health care costs

    Time frame: 18 months

    Direct health care costs

  5. Number of participants that comply with the programme schedules at 3 and 18 months

    Time frame: 3 months and 18 months

    Compliance with the programme: number of undergone interventions out of total prescribed interventions (including activities, referrals or prescriptions)

  6. Number of participants (patients, caregivers and professionals) that are satisfied with the programme at 3 and 18 months

    Time frame: 3 months and 18 months

    Satisfaction with the programme, measured with an ad hoc questionnaire.

Sponsors and collaborators

Lead sponsor

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Other

Collaborators

  • Institut Català de la Salut
  • Instituto de Salud Carlos III

Registry information

Official study title

Frailty Assessment and Multimodal Treatment Strategies in the Elderly at Risk of Adverse Results and Functional Decline in the Community

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Jul 18, 2018
Registry last updated
Sep 1, 2022

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.

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