A Randomized Controlled Trial to Address a Multimodal Intervention in the Elderly

Primary outcomes

1. quality of life

   Time frame: up to 18 months

   The FUMAT scale (Gómez et al., 2008) was used to assess quality of life by means of 8 different dimensions. The higher the score across its eight dimensions, the greater the individual's perceived and objective quality of life. It assesses areas such as emotional well-being, relationships, material well-being, personal well-being, physical well-being, self-determination, inclusion, and rights.

   Gómez, L. E., M. A., V., Arias, B., & Navas, P. (2008). Evaluación de la calidad de vida en personas mayores y con discapacidad: La Escala Fumat. Intervención Psicosocial, 17(2). https://doi.org/10.4321/S1132-05592008000200007

2. Cognitive impairment

   Time frame: up to 18 months

   Cognitive impairment was assessed via the Mini Mental State Examination, MMSE) (Folstein et al., 1975). The MMSE (Mini-Mental State Examination) is a 5-10 minute screening test that assesses cognitive status (orientation, memory, attention, language) through 30 simple questions and tasks. It is scored out of 30, where 24 points suggest cognitive impairment. A higher score indicates better cognitive function.

   Folstein, M. F., Folstein, S. E., & McHugh, P. R. (1975). "Mini-mental state." Journal of Psychiatric Research, 12(3), 189-198. https://doi.org/10.1016/0022-3956(75)90026-6

3. depression

   Time frame: up to 18 months

   The abbreviated version of the Yesavage Geriatric Depression Scale (Martínez de la Iglesia et al., 2002) was used to assess depression.

   The 15-item Abbreviated Geriatric Depression Scale (GDS-15), validated in Spanish by Martínez de la Iglesia et al. (2002), is a reliable, Yes/No questionnaire used to screen for depression in adults over 65. It offers similar diagnostic accuracy to the original 30-item version, typically using a cutoff score >= 5 to indicate depression

4. perceived loneliness

   Time frame: up to 18 months

   Loneliness was assessed using the revised ESTE scale (ESTE-R) (Rubio & Aleixandre, 1999). The ESTE scale is a psychometric tool designed to measure unwanted loneliness in older adults, assessing three key factors: social support, use of new technologies, and social participation. It uses a questionnaire that scores from 0 to 30, determining low, medium, or high levels of loneliness. The higher the total score, the greater the level of loneliness reported by the individual.

   Rubio, R., & Aleixandre, M. (1999). La escala "Este", un indicador objetivo de soledad en la tercera edad. Geriatrika. Revista Iberoamericana de Geriatría y Gerontología, 15, 26-35.

5. Activities of daily living (ADL)

   Time frame: up to 18 months

   The Barthel's scale (F.I. Mahoney & Barthel, 1965) was used to measure the subjects' functional capacity to perform basic activities and tasks of daily living (ADL).The Barthel's scale is a functional assessment tool that measures a person's independence in 10 basic activities of daily living (ADLs) using a score from 0 to 100. It is based on observation or questioning about the ability to eat, bathe, dress, control bowel and bladder control, transfer, and ambulate. A higher score on the scale indicates a greater level of independence.

   F.I. Mahoney, & Barthel, D. W. (1965). Functional Evaluation: The Barthel Index. Md State Med J., 14, 61-65.

6. Instrumental activities of daily living (iADL)

   Time frame: up to 18 months

   Lawton and Brody's test (Lawton & Brody, 1970) was used to measure the ability to perform instrumental activities of daily living (IADL). The Lawton and Brody Scale is a geriatric tool that measures the independence of older adults in performing Instrumental Activities of Daily Living (IADLs). It assesses eight key areas, such as using the telephone, shopping, preparing food, household chores, laundry, transportation, medication management, and finances. Scores are assigned from 0 (dependent) to 1 (independent) per item, for a total of 0 to 8, indicating the degree of autonomy and allowing for early detection of functional decline. Higher scores on the scale indicate greater independence.

   Lawton, M. P., & Brody, E. M. (1970). Assessment of older people: Self-maintaining and instrumental activities of daily living. Nursing Research, 13(3), 278.

7. Tinetti scale

   Time frame: up to 18 months

   Tineti's scale (Tinetti, 1986) was used to assess the balance and gait of older adults and determine the risk of falls. The Tinetti scale is a geriatric assessment tool that measures the risk of falls in older adults by analyzing their balance and gait through direct observation. It scores everyday tasks (sitting, standing, turning, walking) on a scale of 0 to 28, where less than 19 points indicates high risk and more than 25 indicates low risk.

   Tinetti, M. E. (1986). Performance-oriented assessment of mobility problems in elderly patients. J Am Geriatr Soc., 34, 119-126.