Cognitive Decline, Depressive Symptoms, Hearing Loss, Mobility, Nutrition, Healthy, Visual Impairment
Conditions
Keywords
Frailty, Intrinsic capacity, Multicomponent intervention, Randomized clinical Trial, Quality of life
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.
Interventions
OTHERVIVIFRAIL
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/
OTHERNutrition
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.
BEHAVIORALPsychology
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.
BEHAVIORALPersonal autonomy
Review practical cases on personal autonomy, the proper use of medications, and discover basic cognitive stimulation strategies.
OTHERCommunity resources
Learn about community resources
Usual advice provided at primary care office accompanied to booklets about healthy lifestyles
Sponsors
Fundacio Salut i Envelliment UAB
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Open and Pragmatic Parallel Randomized Controlled Clinical Trial
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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). |
| 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. |
| 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. |
| 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).) |
| 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) |
| 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). |
| 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. |
Outcome results
None listed