Implementation of the Integrated Care of Older People App and ICOPE Monitor in Primary Care (ICOPE)

NCT04413877 | Withdrawn DMC

• 1 other identifier: GerULiege/SG/DSR/ICOPE
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Introduction: The World Health Organization has launched the INSPIRE-ICOPE-CARE program towards healthy aging. It includes "intrinsic capacity", defined as "the composite of all the physical and mental capacities of an individual", which has a positive value towards prevention, and is constructed by five domains: cognition, vitality/nutrition, sensory, psychology, and mobility. ICOPE App and ICOPE Monitor are applications for the self-assessment and monitoring of intrinsic capacity. Hypothesis: Intrinsic capacity self-assessed by the ICOPE Apps could be associated with the incidence of frailty and health outcomes. ICOPE Apps might support geriatric and primary care during the COVID-19 pandemic and beyond. Objectives: To assess the association between intrinsic capacity measured by the ICOPE Apps at baseline and the incidence of frailty in community-dwelling older adults during 1-year follow-up. Secondarily, to assess the association of intrinsic capacity and pre-frailty, falls, functional decline, institutionalization, and mortality (COVID-19-related/not related). Methods: Protocol for a cohort study of community-dwelling adults ≥65-year-old, with no other exclusion criteria than the inability to use the Apps or communicate by telephone/video-call for any reason (cognitive or limited access to telephone/video-call). Intrinsic capacity measured by the ICOPE Apps and Rockwood's clinical frailty scale will be assessed at baseline, 4-, 8- and 12-month follow-up by telephone/video-call. Assuming a prevalence of frailty of 10.7%, and incidence of 13% (alpha-risk=0.05), 400 participants at 12-month end-point (relative precision=0.10) and 600 participants at baseline will be required. Associations among the decrease in intrinsic capacity, incidence of frailty, and occurrence of health adverse outcomes during 1-year follow-up are expected. ICOPE Apps might identify individuals at higher risk of frailty and health adverse consequences. The implementation of the ICOPE Apps into clinical practice might help to bring the practitioners closer to their patients, deliver efficient person-centered care-plans, and benefit the healthcare systems during the COVID-19 pandemic and beyond.

Conditions

Frailty Syndrome; COVID-19; Healthy Aging; Old Age; Debility

Keywords

Integrated Care for Older People (ICOPE); COVID-19; Intrinsic capacity; Frailty syndrome; App; Older people

Outcome Measures

Primary Outcomes (1)

• Incidence of frailty

  Incidence of frailty assessed by Rockwood's clinical frailty scale (CFS) will be assessed at baseline and 12-month follow-up by telephone/video-call. An score \<4 will indicate robustness, 4-6 pre-frailty status, and ≥6 frailty

  1 year

Study Arms (1)

Descriptive cohort study

Prospective cohort study of community-dwelling adults ≥65-year-old living at home, with no other exclusion criteria than the inability to use the ICOPE Apps or communicate by telephone/video-call for any reason (cognitive or limited access to technologies like telephone/video-call). Cohort study, designed to determine the incidence of frailty in community-dwelling older people during 1-year follow-up, starting the recruitment at a certain point of the COVID-19 pandemic and beyond.

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Volunteers will be community-dwelling adults ≥65-year-old living at home

Sponsors & Collaborators

• University of Liege: lead
• University Hospital, Toulouse: collaborator

Related Publications (5)

• Sanchez-Rodriguez D, Annweiler C, Gillain S, Vellas B. Implementation of the Integrated Care of Older People (ICOPE) App in Primary Care: New Technologies in Geriatric Care during Quarantine of COVID-19 and Beyond. J Frailty Aging. 2021;10(2):139-140. doi: 10.14283/jfa.2020.24. No abstract available.

  PMID: 33575702 RESULT

• de Kerimel J, Tavassoli N, Lafont C, Soto M, Pedra M, Nourhashemi F, Lagourdette C, Bouchon L, Chaleon A, Sourdet S, Rolland Y, Cesari M, Vellas B. How to Manage Frail Older Adults in the Community? Proposal of a Health Promotion Program Experienced in a City of 16,638 Inhabitants in France. J Frailty Aging. 2018;7(2):120-126. doi: 10.14283/jfa.2017.47.

  PMID: 29741197 RESULT

• Takeda C, Guyonnet S, Sumi Y, Vellas B, Araujo de Carvalho I. Integrated Care for Older People and the Implementation in the INSPIRE Care Cohort. J Prev Alzheimers Dis. 2020;7(2):70-74. doi: 10.14283/jpad.2020.8.

  PMID: 32236394 RESULT

• Cesari M, Araujo de Carvalho I, Amuthavalli Thiyagarajan J, Cooper C, Martin FC, Reginster JY, Vellas B, Beard JR. Evidence for the Domains Supporting the Construct of Intrinsic Capacity. J Gerontol A Biol Sci Med Sci. 2018 Nov 10;73(12):1653-1660. doi: 10.1093/gerona/gly011.

  PMID: 29408961 RESULT

• Belloni G, Cesari M. Frailty and Intrinsic Capacity: Two Distinct but Related Constructs. Front Med (Lausanne). 2019 Jun 18;6:133. doi: 10.3389/fmed.2019.00133. eCollection 2019.

  PMID: 31275941 RESULT

MeSH Terms

Conditions

Frailty; COVID-19; Alzheimer Disease

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Dolores Sanchez-Rodriguez, MD PhD

  Division of Public Health, University of Liège, Liège, Belgium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: May 25, 2020
• First Posted: June 4, 2020
• Study Start: December 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: December 8, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share