- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio 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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Antecipado)
Contactos e Locais
Locais de estudo
-
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Tarragona
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Reus, Tarragona, Espanha
- University Rovira i Virgili
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Reus, Tarragona, Espanha, 43204
- Institut d'Investigació Sanitaria Pere i Virgili
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Risk of sarcopenia (muscle strength)
Prazo: 1 day
|
Reduction of muscle strength: <27kg in men and <16kg in women measured by a dynamometer
|
1 day
|
|
Diagnosis of sarcopenia (muscle strength)
Prazo: 1 day
|
Reduction of muscle strength (<27kg in men and <16kg in women measured by a dynamometer)
|
1 day
|
|
Diagnosis of sarcopenia (muscle mass)
Prazo: 1 day
|
Reduction of muscle mass (<20kg in men and <15kg in women measured by bioimpedance)
|
1 day
|
|
Diagnosis of severe sarcopenia (muscle strength)
Prazo: 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)
Prazo: 1 day
|
Reduction of muscle mass (<20kg in men and <15kg in women measured by bioimpedance)
|
1 day
|
|
Diagnosis of severe sarcopenia (muscle function)
Prazo: 1 day
|
Reduction of muscle function (≤0.8 m / s)
|
1 day
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Nutrition
Prazo: 1 day
|
Food frequency questionnaire (not scale) |
1 day
|
|
Physical activity
Prazo: 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
Prazo: 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
Prazo: 1 day
|
Mini Nutritional Assessment 12-14 points: normal nutritional status 8-11 points: risk of malnutrition 0-7 points: malnutrition
|
1 day
|
|
Weight
Prazo: 1 day
|
Weight using a balance (kg)
|
1 day
|
|
height
Prazo: 1 day
|
Height using a tallimeter (m)
|
1 day
|
|
BMI
Prazo: 1 day
|
Using weight (kg) / height (m)2
|
1 day
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Age
Prazo: 1 day
|
Age in years
|
1 day
|
|
Gender
Prazo: 1 day
|
Female or male
|
1 day
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Rosa Sola, Dr, University Rovira i Virgili
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Antecipado)
Conclusão do estudo (Antecipado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- Earlier-Elderly Urban People
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
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