- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT05268146
Earlier Elderly People in Urban Areas
Characterization, Creativity, Leadership, and Search for Solutions to Improve the Lifestyles of Earlier Elderly People in Urban Areas
Social innovation in aging needs to bring new ideas and services to meet new social and welfare needs identified in recent years. In our environment, people ≥60 years old accounted for 20% -24% of the population in 2015, and it is expected to increase to ≥30% by 2050.
The objectives of this project are: To characterize the elderly (60 to 74 years) who live independently in urban areas of the province of Tarragona, to actively involve them, through a process of participatory research to generate solutions.
To achieve this goal, it is proposed to make a diagnosis of their health status (lifestyles, risk of malnutrition, and sarcopenia), and conduct focus groups including young seniors from urban areas, and stakeholders, to determine their needs, interests, and barriers for pursuing healthy lifestyles. Based on the information obtained in the diagnosis and focus groups, there will be processes for co-creating solutions based on proposed activities or changes in their immediate environment.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Social innovation in aging needs to bring new ideas and services to meet new social and welfare needs identified in recent years. In our environment, people ≥60 years old accounted for 20% -24% of the population in 2015, and it is expected to increase to ≥30% by 2050. For the first time in history, most people can aspire to live well beyond the age of 60. On the other hand, the Covid-19 pandemic has severely affected people ≥60 years of age and may make the welfare and health problems of this population more evident, such as unhealthy lifestyles, the risk of malnutrition, and sarcopenia (defined as loss of muscle mass, strength, and function), which leads to significant dependency and quality of life problems. In addition, older people living in urban areas have been severely affected by confinement, and new needs are being generated. To better understand the needs, an innovative element of this project is to involve the elderly-young people (60-74 years) from urban areas in the generation of solutions, which will make these solutions especially adapted to their needs. Therefore increase the adherence to the solutions created, and also the long-term sustainability of the solutions.
The objectives of this project are: To characterize the elderly (60 to 74 years) who live independently in urban areas of the province of Tarragona, to actively involve them, through a process of participatory research to generate solutions.
To achieve this goal, it is proposed to make a diagnosis of their health status (lifestyles, risk of malnutrition, and sarcopenia), and conduct focus groups including young seniors from urban areas, and stakeholders, to determine their needs, interests, and barriers for pursuing healthy lifestyles. Based on the information obtained in the diagnosis and focus groups, there will be processes for co-creating solutions based on proposed activities or changes in their immediate environment. During the co-creation process, the elderly and the 4-helix stakeholders (government, industry, university, and civil society) will be involved.
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Ubicaciones de estudio
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Tarragona
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Reus, Tarragona, España
- University Rovira i Virgili
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Reus, Tarragona, España, 43204
- Institut d'Investigació Sanitaria Pere i Virgili
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- People ≥60 years and ≤75 years,
- That they have informed consent,
- Living at home (living independently), Community-dwelling early-elderly
- That they can continue the study,
- They live in the province of Tarragona
Exclusion Criteria:
- Failure to comply with the inclusion criteria will be considered an exclusion criterion.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Risk of sarcopenia (muscle strength)
Periodo de tiempo: 1 day
|
Reduction of muscle strength: <27kg in men and <16kg in women measured by a dynamometer
|
1 day
|
|
Diagnosis of sarcopenia (muscle strength)
Periodo de tiempo: 1 day
|
Reduction of muscle strength (<27kg in men and <16kg in women measured by a dynamometer)
|
1 day
|
|
Diagnosis of sarcopenia (muscle mass)
Periodo de tiempo: 1 day
|
Reduction of muscle mass (<20kg in men and <15kg in women measured by bioimpedance)
|
1 day
|
|
Diagnosis of severe sarcopenia (muscle strength)
Periodo de tiempo: 1 day
|
Reduction of muscle strength (<27kg in men and <16kg in women measured by a dynamometer) and
|
1 day
|
|
Diagnosis of severe sarcopenia (muscle mass)
Periodo de tiempo: 1 day
|
Reduction of muscle mass (<20kg in men and <15kg in women measured by bioimpedance)
|
1 day
|
|
Diagnosis of severe sarcopenia (muscle function)
Periodo de tiempo: 1 day
|
Reduction of muscle function (≤0.8 m / s)
|
1 day
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Nutrition
Periodo de tiempo: 1 day
|
Food frequency questionnaire (not scale) |
1 day
|
|
Physical activity
Periodo de tiempo: 1 day
|
International physical activity questionnaire for elderly Low category: non-physical activity or it is not enough to achieve moderate or high category Moderate category: 3 or more days / weeks (vigorous physical activity, at least 25 minutes/day), or 5 or more (moderate physical activity, at least 30 minutes/day), or 5 or more days / weeks of a combination of walking, or moderate-vigorous physical activity (at least 600 METS). High category: 7 or more days / week of a combination of walking, or moderate-vigorous physical activity (at least 3000 METS). |
1 day
|
|
Sleep behaviour
Periodo de tiempo: 1 day
|
Pittsburg questionnaire Pittsburg questionnaire The questionnaire contains a total of 19 questions, grouped into 10 questions. The 19 questions are combined to form seven areas with their corresponding score, each of which shows a range between 0 and 3 points. In all cases, a score of "0" indicates ease, while a score of 3 indicates severe difficulty, within their respective area. The score of the seven areas is finally added to give an overall score, which ranges from 0 to 21 points. "0" indicates ease of sleeping and "21" severe difficulty in all areas. |
1 day
|
|
Risk of malnutrition
Periodo de tiempo: 1 day
|
Mini Nutritional Assessment 12-14 points: normal nutritional status 8-11 points: risk of malnutrition 0-7 points: malnutrition
|
1 day
|
|
Weight
Periodo de tiempo: 1 day
|
Weight using a balance (kg)
|
1 day
|
|
height
Periodo de tiempo: 1 day
|
Height using a tallimeter (m)
|
1 day
|
|
BMI
Periodo de tiempo: 1 day
|
Using weight (kg) / height (m)2
|
1 day
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Age
Periodo de tiempo: 1 day
|
Age in years
|
1 day
|
|
Gender
Periodo de tiempo: 1 day
|
Female or male
|
1 day
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Rosa Sola, Dr, University Rovira i Virgili
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Earlier-Elderly Urban People
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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