Effectiveness of AMICOPE Intervention to Maintain Self-Perceived Health and Intrinsic Capacity in Older People

NCT ID: NCT05249504

Last Updated: 2022-02-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 212 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-01
• Study Completion Date: 2024-08-31

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.

Conditions

Mobility; Depressive Symptoms; Nutrition, Healthy; Cognitive Decline; Hearing Loss; Visual Impairment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

1. Intervention group

AMICOPE 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

Group Type: EXPERIMENTAL

VIVIFRAIL

Intervention Type: OTHER

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/

Nutrition

Intervention Type: OTHER

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.

Psychology

Intervention Type: BEHAVIORAL

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.

Personal autonomy

Intervention Type: BEHAVIORAL

Review practical cases on personal autonomy, the proper use of medications, and discover basic cognitive stimulation strategies.

Community resources

Intervention Type: OTHER

Learn about community resources

2. Control group

Control group participants will receive usual advice on healthy lifestyle habits and a follow-up phone call from healthcare professionals.

Group Type: ACTIVE_COMPARATOR

Standard recommendations

Intervention Type: OTHER

Usual advice provided at primary care office accompanied to booklets about healthy lifestyles

Interventions

VIVIFRAIL

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/

Intervention Type: OTHER

Nutrition

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.

Intervention Type: OTHER

Psychology

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.

Intervention Type: BEHAVIORAL

Personal autonomy

Review practical cases on personal autonomy, the proper use of medications, and discover basic cognitive stimulation strategies.

Intervention Type: BEHAVIORAL

Community resources

Learn about community resources

Intervention Type: OTHER

Standard recommendations

Usual advice provided at primary care office accompanied to booklets about healthy lifestyles

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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).

Exclusion Criteria

• 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.

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundacio Salut i Envelliment UAB

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

PI21/00537

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

5876

Identifier Type: OTHER

Identifier Source: secondary_id

FSIEPI2100537

Identifier Type: -

Identifier Source: org_study_id