Effectiveness of a Socio-Community Health Intervention on Pre-Frailty in Older Adults

Официальное название

Effectiveness of a Health Intervention With a Socio-community Approach on Frailty in Older Adults With Pre-frailty

Обзор

The objective of this study is: To evaluate the effectiveness of a health intervention with a socio-community approach on frailty in older adults with pre-frailty. Specific Objectives: To characterize the study population according to sociodemographic and clinical variables. To evaluate the effect of the intervention on the functionality domain at 3 and 6 months. To evaluate the effect of the intervention on the cognitive-emotional domain at 3 and 6 months. To evaluate the effect of the intervention on the socio-community domain at 3 and 6 months. To evaluate the effect of the intervention on frailty in older adults. To determine the proportion of participants hospitalized during the study period. To determine the proportion of participants who visited the emergency room during the study period. To determine the proportion of participants in long-term care facilities. To determine the proportion of adverse events associated with the intervention. Study Hypothesis The mean frailty score pre-intervention is equal to the mean frailty score post-intervention. The mean frailty score pre-intervention is different from the mean frailty score post-intervention.

Вмешательства

• Поведенческое health intervention with a socio-community approach
  The intervention consists of five components, including education, cognitive stimulation, physical activity, nutrition, and socio-community aspects. The duration of the intervention will be 6 months and will be conducted in either in-person or virtual format, individually or in groups, depending on the nature of each component. Mode of Delivery: The intervention will be offered in both in-person and synchronous virtual formats. Participants who are unable to attend in person or who face difficu

Первичные конечные точки

• Score on the FRAIL Scale [Срок оценки: Baseline, 3, 6 Months]

Вторичные конечные точки (12)

• Barthel Index [Срок оценки: Baseline, 3, 6 Months]
• Lawton Score [Срок оценки: Baseline, 3, 6 Months]
• Downton Scale [Срок оценки: Baseline, 3, 6 Months]
• Score on the Montreal Cognitive Assessment (MoCA) [Срок оценки: Baseline, 3, 6 Months]
• Score on the Yesavage Geriatric Depression Scale (GDS) [Срок оценки: Baseline, 3, 6 Months]
• Score on the Gijón Family-Social Assessment Scale [Срок оценки: Baseline, 3, 6 Months]
• Score on the Lubben Social Network Scale [Срок оценки: Baseline, 3, 6 Months]
• Health-Related Quality of Life Measured by EQ-5D-3L [Срок оценки: Baseline, 3, 6 Months]
• Number of Hospital Admissions [Срок оценки: During the 6-month intervention]
• Total Number of Hospitalization Days [Срок оценки: During the 6-month intervention]
• Total Number of Emergency Room Admissions [Срок оценки: During the 6-month intervention.]
• Requirement for Admission to Long-Term Care Facilities [Срок оценки: During the 6-month intervention.]

Критерии участия

Критерии включения

• Individuals ≥ 60 years old classified as pre-frail in the last 3 months and documented in their medical history.
• Individuals who meet the requirements and provide voluntary informed consent for their participation.
• Individuals available to remain in Bogotá D.C. during the study period.

Критерии исключения

• Individuals receiving care at community-focused medical centers.
• Individuals attending community dining programs, physical activity programs, community groups, care blocks, volunteering, or other related activities.
• Individuals who have experienced falls in the last 6 months with clinical consequences (hospitalization, fractures, traumatic brain injury).
• Individuals with a clinical history of moderate cognitive impairment, neurodegenerative diseases (e.g., Parkinson's disease), and/or neuro-musculoskeletal disorders, active cancer, end-stage renal disease, unstable ischemic heart disease, uncontrolled arrhythmias, severe aortic stenosis, uncontrolled hypertension (>180/100 mmHg), or advanced heart failure, exacerbation of chronic diseases (COPD, heart failure), unrehabilitated severe hearing loss, deafness, or blindness with communication limitations.
• Acute conditions requiring hospitalization, such as acute myocardial infarction or urinary tract infections.
• Bone fractures in the last 3 months.
• Individuals unable to follow instructions or with behavioral changes that hinder their participation in the study.
• Individuals with severe psychiatric illness that, in the physician's judgment, prevents proper adherence to the study intervention.
• Institutionalized individuals in long-term care facilities.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06663150 · 092-24 UNV

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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