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

Primary Purpose

Mobility, Depressive Symptoms, Nutrition, Healthy

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
VIVIFRAIL
Nutrition
Psychology
Personal autonomy
Community resources
Standard recommendations
Sponsored by
Fundacio Salut i Envelliment UAB
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Mobility focused on measuring Frailty, Intrinsic capacity, Multicomponent intervention, Randomized clinical Trial, Quality of life

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    1. Intervention group

    2. Control group

    Arm Description

    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

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

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Functional status
    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
    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)
    Depressive symptoms
    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).
    Autonomy in daily life.
    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.
    Change in health related quality of life will be assessed with the quality of life questionnaire EQ-5D-5L.
    Physical activity.
    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).)
    Loneliness
    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)
    Social support and risk of isolation
    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).

    Full Information

    First Posted
    December 15, 2021
    Last Updated
    February 10, 2022
    Sponsor
    Fundacio Salut i Envelliment UAB
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05249504
    Brief Title
    Effectiveness of AMICOPE Intervention to Maintain Self-Perceived Health and Intrinsic Capacity in Older People
    Acronym
    EFICIS
    Official Title
    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)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 1, 2022 (Anticipated)
    Primary Completion Date
    June 30, 2023 (Anticipated)
    Study Completion Date
    August 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Fundacio Salut i Envelliment UAB

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Mobility, Depressive Symptoms, Nutrition, Healthy, Cognitive Decline, Hearing Loss, Visual Impairment
    Keywords
    Frailty, Intrinsic capacity, Multicomponent intervention, Randomized clinical Trial, Quality of life

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Open and Pragmatic Parallel Randomized Controlled Clinical Trial
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    212 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    1. Intervention group
    Arm Type
    Experimental
    Arm Description
    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
    Arm Title
    2. Control group
    Arm Type
    Active Comparator
    Arm Description
    Control group participants will receive usual advice on healthy lifestyle habits and a follow-up phone call from healthcare professionals.
    Intervention Type
    Other
    Intervention Name(s)
    VIVIFRAIL
    Intervention Description
    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
    Intervention Name(s)
    Nutrition
    Intervention Description
    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
    Behavioral
    Intervention Name(s)
    Psychology
    Intervention Description
    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
    Intervention Name(s)
    Personal autonomy
    Intervention Description
    Review practical cases on personal autonomy, the proper use of medications, and discover basic cognitive stimulation strategies.
    Intervention Type
    Other
    Intervention Name(s)
    Community resources
    Intervention Description
    Learn about community resources
    Intervention Type
    Other
    Intervention Name(s)
    Standard recommendations
    Intervention Description
    Usual advice provided at primary care office accompanied to booklets about healthy lifestyles
    Primary Outcome Measure Information:
    Title
    Self-perceived health
    Description
    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
    Time Frame
    Baseline, after the intervention (average 16 weeks)
    Secondary Outcome Measure Information:
    Title
    Functional status
    Description
    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.
    Time Frame
    Baseline, after the intervention (average 16 weeks)
    Title
    Nutritional status
    Description
    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)
    Time Frame
    Baseline, after the intervention (average 16 weeks)
    Title
    Depressive symptoms
    Description
    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).
    Time Frame
    Baseline, after the intervention (average 16 weeks)
    Title
    Autonomy in daily life.
    Description
    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.
    Time Frame
    Baseline, after the intervention (average 16 weeks)
    Title
    Health related quality of life.
    Description
    Change in health related quality of life will be assessed with the quality of life questionnaire EQ-5D-5L.
    Time Frame
    Baseline, after the intervention (average 16 weeks)
    Title
    Physical activity.
    Description
    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).)
    Time Frame
    Baseline, after the intervention (average 16 weeks)
    Title
    Loneliness
    Description
    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)
    Time Frame
    Baseline, after the intervention (average 16 weeks)
    Title
    Social support and risk of isolation
    Description
    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).
    Time Frame
    Baseline, after the intervention (average 16 weeks)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    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.

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    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.
    IPD Sharing Time Frame
    The data can be requested 18 months after publishing the results.
    IPD Sharing 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.

    Learn more about this trial

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

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