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

Not Applicable

Not yet recruiting

• Conditions: Depressive Symptoms; Nutrition, Healthy; Hearing Loss; Visual Impairment; Mobility; Cognitive Decline
• Interventions: Other: VIVIFRAIL; Other: Standard recommendations; Other: Nutrition; Behavioral: Psychology; Behavioral: Personal autonomy; Other: Community resources

• Registration Number: NCT05249504
• Lead Sponsor: Fundacio Salut i Envelliment UAB

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-15
• Status Verified: 2022-02
• Study First Submitted QC: 2022-02-10
• Last Update Submitted: 2022-02-10
• Study First Posted: 2022-02-21
• Last Update Posted: 2022-02-21
• Study Start: 2022-04-01
• Primary Completion: 2023-06-30
• Study Completion: 2024-08-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 212

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1. Intervention group	VIVIFRAIL	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
1. Intervention group	Personal autonomy	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
1. Intervention group	Community resources	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
1. Intervention group	Psychology	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
2. Control group	Standard recommendations	Control group participants will receive usual advice on healthy lifestyle habits and a follow-up phone call from healthcare professionals.
1. Intervention group	Nutrition	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

Primary Outcome Measures

Name	Time	Method
Self-perceived health	Baseline, after the intervention (average 16 weeks)	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

Secondary Outcome Measures

Name	Time	Method
Autonomy in daily life.	Baseline, after the intervention (average 16 weeks)	Change in the ability to perform basic and instrumental daily life activities will be measured with the Short-Form Late-Life Function and Disability Instrument (SF-LLFDI).; Higher scores indicates a higher level of autonomy.
Health related quality of life.	Baseline, after the intervention (average 16 weeks)	Change in health related quality of life will be assessed with the quality of life questionnaire EQ-5D-5L.
Depressive symptoms	Baseline, after the intervention (average 16 weeks)	Change in proportion of participants with depressive symptoms using the 5 items Geriatric Depression Scales (GDS5). Not depressed (0 or 1 point), Depressed (2-5).
Physical activity.	Baseline, after the intervention (average 16 weeks)	Change in level of physical activity, which will be assessed with the Spanish Short Version of the Minnesota Leisure Time Physical Activity Questionnaire (VREM), which according to the time doing several activities computes the energy expenditure in units that can be compared between them, the Metabolic Equivalent of Task. (MET). Persons are categorized as sedentary (\< 1.250 METs-min/14 days), moderately active (1.250 to 2.999 METs-min/14 days); active (3.000 to 4.999 METs-min/14 days) or very active (≥ 5.000 METs-min/14 days).)
Functional status	Baseline, after the intervention (average 16 weeks)	Change in functional status according to the Short Physical Performance Battery (SPPB), a set of tests that measure balance, gait speed and strength (raising 5 times from a chair). Persons are classified in categories according to their final score (0-3, 4-6, 7-9, 10-12). Higher scores indicates robustness, lower scores are indicative of frailty and disability.
Nutritional status	Baseline, after the intervention (average 16 weeks)	Change in nutritional risks assessed by the abridged version of Mini-Nutritional Assessment (MNA), which classifies the persons as normal (12-14 points), at risk of malnutrition (8-11) or malnourished (0-7)
Social support and risk of isolation	Baseline, after the intervention (average 16 weeks)	Change in social support and risk of isolation, which will be assessed with the Lubben Social Network Scale - Revised (LSNS-R). According the the LSNS-R score the persons will be classified as with low risk (30 to 60 points); mild (26 to 30); high (21 to 25) or socially isolated (0 to 20).
Loneliness	Baseline, after the intervention (average 16 weeks)	Change in the degree of Loneliness, which will be assessed with De Jong Gierveld Loneliness Scale. The degree of loneliness is scored as no loneliness (0 to 2 points), mild loneliness ( 3 to 8), severe (9 to 10) or very severe (11)