Effectiveness of AMICOPE Intervention to Maintain Self-Perceived Health and Intrinsic Capacity in Older People
EFICIS
Efectividad de la intervención AMICOPE Para Mejorar y/o Mantener la Salud Autopercibida y la Capacidad intrínseca en Personas Mayores: un Ensayo clínico Aleatorizado (EFICIS)
3 other identifiers
interventional
212
0 countries
N/A
Brief Summary
In their day to day, persons do from simple to more or less complicated tasks and activities (ie: stand from a chair, open a door, shopping, read, drive, play chess, remind an appointment...). Such ability to do things is called capacity. Intrinsic capacity is the combination of all the physical and mental capacities that a person has, and reach its maximum in the early adulthood and then declines as the person ages. Each kind of capacity declines at her own speed (which may be faster or slower according to each person lifestyle), and once drops below a threshold may lead to a reduction in quality of life and loss of autonomy. Nevertheless there are some actions that may be effective to prevent or slow such decline. To do so the investigators have design an intervention that combines several things of different nature (what is know as a complex intervention) called AMICOPE. The AMICOPE intervention is performed in the community or in primary care centers through 12 weekly group sessions of 2 h 30 min which combine structured and adapted physical activity, group dynamics to promote social support and address loneliness, social isolation and depressive symptoms, and dietary advice. Our study is addressed to persons over 70 with light problems in mobility, nutrition or mood state. The purpose of this study is to assess if the AMICOPE intervention is better than the standard advice to follow healthy lifestyles to improve or maintain self-perceived health, mobility, nutritional status an psychological wellbeing.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2022
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 15, 2021
CompletedFirst Posted
Study publicly available on registry
February 21, 2022
CompletedStudy Start
First participant enrolled
April 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2024
CompletedFebruary 21, 2022
February 1, 2022
1.2 years
December 15, 2021
February 10, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Self-perceived health
Change in self-perceived health status according to the Euroqol Visual Analogue Scale, where participants scores from 0 (worse state) to 100 (better state) their current perceived health
Baseline, after the intervention (average 16 weeks)
Secondary Outcomes (8)
Functional status
Baseline, after the intervention (average 16 weeks)
Nutritional status
Baseline, after the intervention (average 16 weeks)
Depressive symptoms
Baseline, after the intervention (average 16 weeks)
Autonomy in daily life.
Baseline, after the intervention (average 16 weeks)
Health related quality of life.
Baseline, after the intervention (average 16 weeks)
- +3 more secondary outcomes
Study Arms (2)
1. Intervention group
EXPERIMENTALAMICOPE multicomponent intervention: * Physical activity (VIVIFRAIL program): 10 hours. * Nutrition: 6,5 hours. * Psychology: 6,5 hours. * Personal autonomy: 4,5 hours * Learn about community resources: 2, 5 hours
2. Control group
ACTIVE COMPARATORControl group participants will receive usual advice on healthy lifestyle habits and a follow-up phone call from healthcare professionals.
Interventions
VIVIFRAIL is a set of physical activity programs (designed according to several elderly functional level profiles) aimed to prevent motor disability and improve quality of life. It works endurance, flexibility, balance and strength. https://web.archive.org/web/20210907041944/https://vivifrail.com/
Sessions to learn about personal nutrition habits, offer nutritional advice, and acquire skills to incorporate simple healthy nutrition guidelines into everyday life. A visit to a supermarket to make it easier to read and understand the basic information on nutrition labels.
Relaxation techniques to manage mood, a photo-elicitation dynamic to address loneliness, and a dynamic to collectively develop a map of health assets in the neighborhood or territory to obtain information on community resources. Finally, a group visit is planned to a community facility previously agreed upon by the participants.
Review practical cases on personal autonomy, the proper use of medications, and discover basic cognitive stimulation strategies.
Usual advice provided at primary care office accompanied to booklets about healthy lifestyles
Eligibility Criteria
You may qualify if:
- To live in the community
- To be able to move autonomously to the intervention place
- To Have a deficit in at least one mobility, vitality or psychological domains in the Integrated Care for Older People (ICOPE) screening tool confirmed by a reference test, namely:
- A - Mobility: unable to stand up from a chair 5 times in less than 14 seconds AND having less than 10 points in the Short Physical Performance Battery (SPPB).
- B - Vitality: any nutritional problem from the ICOPE screening tool (loss of appetite OR losing more than 3 Kg not intentionally in the last 3 months) AND having less than 12 points in MNA (malnutrition or malnutrition risc).
- C - Psychological: any depressive symptoms from the ICOPE screening tool (answer that in the last two weeks has had feelings of sadness, melancholy OR hopelessness or refer lack of interest or pleasure when doing things) AND the presence of at least two or more symptoms on the 5-item Geriatric Depression Scale (GDS5).
You may not qualify if:
- People with previous diagnosis of dementia or cognitive decline with a score below 24 points in the Minimental State Examination (MMSE).
- People in the end of life.
- People who have factors that prevent or contraindicate the performance of the planned interventions, such as contraindication to physical activity, mental or (non-corrected) communication issues that makes it difficult to participate in group dynamics.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 15, 2021
First Posted
February 21, 2022
Study Start
April 1, 2022
Primary Completion
June 30, 2023
Study Completion
August 31, 2024
Last Updated
February 21, 2022
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- The data can be requested 18 months after publishing the results.
- Access Criteria
- Upon request by non-profit organizations. The purpose of the request must match the purpose for which the participants have given their sharing consent. Requester must cite and recognize the source of the data in their works, as far as the funds that the project has received.
The sponsor only will share data from participants that have provided written consent to share its anonymized data for studies with scientific purposes related with well-being, quality of life and autonomy of the elderly persons. Once the database is closed all identifying data collected to develop the study (ie: names and contact phones to make appointments) will be removed from the database. Any date variable will be replaced by a time reference variable, taking as reference the day of the first visit (ie: instead of date of birth and date of visit, will be replaced by the age). Other actions may be performed to ensure a reasonable balance between the data loss and the risk of re-identification, as editing quasi-identificatory variables (ie categorizing/aggregating participant data, as creating age groups) or removed (ie removing the data identifying the centers) or removing cases with a high degree of singularity given the quasi-identificatory variables combination.