- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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 di studio
Iscrizione (Anticipato)
Contatti e Sedi
Luoghi di studio
-
-
Tarragona
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Reus, Tarragona, Spagna
- University Rovira i Virgili
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Reus, Tarragona, Spagna, 43204
- Institut d'Investigació Sanitaria Pere i Virgili
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-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Risk of sarcopenia (muscle strength)
Lasso di tempo: 1 day
|
Reduction of muscle strength: <27kg in men and <16kg in women measured by a dynamometer
|
1 day
|
|
Diagnosis of sarcopenia (muscle strength)
Lasso di tempo: 1 day
|
Reduction of muscle strength (<27kg in men and <16kg in women measured by a dynamometer)
|
1 day
|
|
Diagnosis of sarcopenia (muscle mass)
Lasso di tempo: 1 day
|
Reduction of muscle mass (<20kg in men and <15kg in women measured by bioimpedance)
|
1 day
|
|
Diagnosis of severe sarcopenia (muscle strength)
Lasso di tempo: 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)
Lasso di tempo: 1 day
|
Reduction of muscle mass (<20kg in men and <15kg in women measured by bioimpedance)
|
1 day
|
|
Diagnosis of severe sarcopenia (muscle function)
Lasso di tempo: 1 day
|
Reduction of muscle function (≤0.8 m / s)
|
1 day
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Nutrition
Lasso di tempo: 1 day
|
Food frequency questionnaire (not scale) |
1 day
|
|
Physical activity
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 1 day
|
Mini Nutritional Assessment 12-14 points: normal nutritional status 8-11 points: risk of malnutrition 0-7 points: malnutrition
|
1 day
|
|
Weight
Lasso di tempo: 1 day
|
Weight using a balance (kg)
|
1 day
|
|
height
Lasso di tempo: 1 day
|
Height using a tallimeter (m)
|
1 day
|
|
BMI
Lasso di tempo: 1 day
|
Using weight (kg) / height (m)2
|
1 day
|
Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Age
Lasso di tempo: 1 day
|
Age in years
|
1 day
|
|
Gender
Lasso di tempo: 1 day
|
Female or male
|
1 day
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Rosa Sola, Dr, University Rovira i Virgili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- Earlier-Elderly Urban People
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Informazioni su farmaci e dispositivi, documenti di studio
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