- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Očekávaný)
Kontakty a umístění
Studijní místa
-
-
Tarragona
-
Reus, Tarragona, Španělsko
- University Rovira i Virgili
-
Reus, Tarragona, Španělsko, 43204
- Institut d'Investigació Sanitaria Pere i Virgili
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Risk of sarcopenia (muscle strength)
Časové okno: 1 day
|
Reduction of muscle strength: <27kg in men and <16kg in women measured by a dynamometer
|
1 day
|
|
Diagnosis of sarcopenia (muscle strength)
Časové okno: 1 day
|
Reduction of muscle strength (<27kg in men and <16kg in women measured by a dynamometer)
|
1 day
|
|
Diagnosis of sarcopenia (muscle mass)
Časové okno: 1 day
|
Reduction of muscle mass (<20kg in men and <15kg in women measured by bioimpedance)
|
1 day
|
|
Diagnosis of severe sarcopenia (muscle strength)
Časové okno: 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)
Časové okno: 1 day
|
Reduction of muscle mass (<20kg in men and <15kg in women measured by bioimpedance)
|
1 day
|
|
Diagnosis of severe sarcopenia (muscle function)
Časové okno: 1 day
|
Reduction of muscle function (≤0.8 m / s)
|
1 day
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Nutrition
Časové okno: 1 day
|
Food frequency questionnaire (not scale) |
1 day
|
|
Physical activity
Časové okno: 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
Časové okno: 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
Časové okno: 1 day
|
Mini Nutritional Assessment 12-14 points: normal nutritional status 8-11 points: risk of malnutrition 0-7 points: malnutrition
|
1 day
|
|
Weight
Časové okno: 1 day
|
Weight using a balance (kg)
|
1 day
|
|
height
Časové okno: 1 day
|
Height using a tallimeter (m)
|
1 day
|
|
BMI
Časové okno: 1 day
|
Using weight (kg) / height (m)2
|
1 day
|
Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Age
Časové okno: 1 day
|
Age in years
|
1 day
|
|
Gender
Časové okno: 1 day
|
Female or male
|
1 day
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Rosa Sola, Dr, University Rovira i Virgili
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Očekávaný)
Dokončení studie (Očekávaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- Earlier-Elderly Urban People
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