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NCT Number: NCT06140212

Exploring the Relationship Between ICOPE Framework and Frailty Among Community-dwelling Elderly Individuals

This study aims to (1) compare the assessment outcome of the ICOPE-I and ICOPE-S, and (2) investigate the correlation between both versions of the ICOPE step 1 screening tools and frailty in Taiwan.

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Key information

Conditions

Community-dwelling Elderly Frailty Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University

Taipei, Zhongzheng, 100, Taiwan

About this study

The prevalence of frailty among the elderly increases annually as the population ages. The World Health Organization (WHO) has introduced the Integrated Care for Older People (ICOPE) framework, which aims to support healthy aging by evaluating the intrinsic capacity (IC) of the elderly in six different areas. In Taiwan, two versions of the ICOPE step 1 screening tools are available: an interview-based version (ICOPE-I) and a self-administered version (ICOPE-S) based on the WHO's model. There are two main models for frailty status assessments: Dr. Fried's phenotype of frailty and Dr. Rockwood's accumulation of deficit models. A comparative study is necessary to assess the consistency of both versions of ICOPE in Taiwan and their associations with frailty.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • ≥ 65 years old
  • Community-dwelling elderly
  • Walking independently (with/without assistive devices)

Exclusion criteria

  • Participants with a MoCA score < 26
  • Being unable to give informed consent (e.g., aphasia, deafness, and blindness)
  • Being unable to finish all the physical and screening assessment assessments

Treatment and study plan

MOntreal Cognitive Assessment (MoCA)

Behavioral

MoCA would be used to assess participants cognitive functioning.

Chinese ICOPE screening tool (self-administration and interview versions)

Behavioral

The ICOPE screening tool would be used to assess participants health status, including cognitive decline, auditory and visual capabilities, mobility restrictions, nutritional status, and depressive symptoms.

Frailty status assessment (Edmonton frail scale and Frailty criteria by Dr. Fried)

Behavioral

The Edmonton frail scale and Frailty criteria by Dr. Fried would be used to assess participants frailty status.

Primary outcomes

  1. Intrinsic capacity

    Time frame: The ICOPE screening tool assessment would take about 10 minutes

    ICOPE screening tool (self-administration and interview version) would be used to evaluate the intrinsic capacity(IC), including cognitive decline, auditory and visual capabilities, mobility restrictions, nutritional status, and depressive symptoms) of the participants.

    Each question requires a binary response, either 'yes' or 'no'. A "total score" will be determined by summing the number of IC impairments, which have a score range of 0-6, with higher scores indicating a greater degree of impairment.

  2. Phenotype of frailty status

    Time frame: The phenotype of frailty status assessment would take about 10 minutes

    Frailty criteria by Dr. Fried would be used to evaluate the frail status of the participants.The Dr. Fried phenotype of frailty comprises five components, unintentional weight loss, exhaustion, weakness, slowness, and low activity. Individuals who exhibit three or more indicators are classified as frail, those with one to two indicators are categorized as pre-frail, and those with no indicators are characterized as robust.

  3. Accumulated frailty status

    Time frame: The accumulated frailty status assessment would take about 10 minutes

    Edmonton frail scale(EFS) would be used to evaluate the frail status of the participants. EFS assesses a wide range of nine domains through 11 questions. These domains cover cognition, general health status, functional independence, social support, medication use, nutrition, mood, continence, and functional performance. The total score of EFS ranges from 0 to 17, where scores of 0-5 indicate not being frail, 6-7 indicate being vulnerable, 8-9 indicate mild frailty, 10-11 indicate moderate frailty and 12-17 indicate severe frailty.

Secondary outcomes

  1. Cognitive status

    Time frame: The cognitive status assessment would take about 10 minutes

    MoCA would be used to evaluate the cognitive functioning of the participants. MOCA comprises attention and concentration, executive function, memory, language ability, visuospatial construction, abstract concepts, calculation, and orientation. The cumulative score amounts to 30 points, with a minimum standard of 26 points or higher. 25-18 points indicate mild cognitive impairment, 17-10 points indicate moderate cognitive impairment, fewer than 10 points indicate severe cognitive impairment.

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

Exploring the Relationship Between the Integrated Care for Older People (ICOPE) Framework and Frailty Among Community-dwelling Elderly Individuals

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 18, 2023
Registry last updated
Aug 12, 2024

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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