跳至主要内容
临床试验/NCT05273502
NCT05273502Unknown不适用

Characterization, Creativity, Leadership, and Search for Solutions to Improve the Lifestyles of Earlier Elderly People in Rural Areas

University Rovira i Virgili1 个研究点 分布在 1 个国家目标入组 176 人开始时间: 2022年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
176
试验地点
1
主要终点
Diagnosis of sarcopenia (muscle mass)

研究概览

简要总结

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. Older people living in rural 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 rural areas in the generation of solutions, which will make these solutions especially adapted to their needs. It also aims to study the effectiveness of a health education intervention based on participatory research, where young seniors co-create and implement the intervention among their peers, and focused on improving lifestyles, to prevent or to improve sarcopenia.

The objectives of this project are: To characterize the elderly (60 to 74 years) who live independently in rural 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 group interviews (focus groups) including earlier elderly people from rural areas. In addition, participants will receive the intervention co-created by themselves, and the effectiveness of the intervention created will be evaluated.

详细描述

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 rural 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 rural 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. It also aims to study the effectiveness of a health education intervention based on participatory research, where young seniors co-create and implement the intervention among their peers, and focused on improving lifestyles, to prevent or to improve sarcopenia.

The objectives of this project are: To characterize the elderly (60 to 74 years) who live independently in rural 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 group interviews (focus groups) including earlier elderly people from rural areas, and the sectors involved, to determine their needs, interests, and barriers to pursuing healthy lifestyles. Based on the information obtained in the diagnosis and group interviews, 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 sectors involved in the 4-helix (government, industry, university, and civil society) will be involved. In addition, participants will receive the intervention co-created by themselves, and the effectiveness of the intervention created will be evaluated.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

盲法说明

This is an educational program, so that, the intervention group will know that will receive some educational and behavioral activities, and the control group will know that they will not receive any kind of activities.

入排标准

年龄范围
60 Years 至 74 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •People ≥60 years and ≤74 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.

排除标准

  • •Failure to comply with the inclusion criteria will be considered an exclusion criterion.

研究组 & 干预措施

Citizen Science Behavioral Intervention

Experimental

The intervention group (IG) participants will receive the whole citizen science intervention of the project, and participants will be assessed at baseline and end-of-study.

干预措施: Citizen Science intervention (Behavioral)

Control group

No Intervention

The controls group (CG) participants will not receive any kind of intervention, and participants will only be assessed at baseline and end-of-study.

结局指标

主要结局

Diagnosis of sarcopenia (muscle mass)

时间窗: Baseline and through study completion, an average of 1 year

Change of muscle mass (\<20kg in men and \<15kg in women measured by bioimpedance)

Diagnosis of severe sarcopenia (muscle strength)

时间窗: Baseline and through study completion, an average of 1 year

Change of muscle strength (\<27kg in men and \<16kg in women measured by a dynamometer)

Risk of sarcopenia (muscle strength)

时间窗: Baseline and through study completion, an average of 1 year

Change of muscle strength: \<27kg in men and \<16kg in women measured by a dynamometer

Diagnosis of sarcopenia (muscle strength)

时间窗: Baseline and through study completion, an average of 1 year

Change of muscle strength (\<27kg in men and \<16kg in women measured by a dynamometer)

Diagnosis of severe sarcopenia (muscle mass)

时间窗: Baseline and through study completion, an average of 1 year

Change of muscle mass (\<20kg in men and \<15kg in women measured by bioimpedance)

Diagnosis of severe sarcopenia (muscle function)

时间窗: Baseline and through study completion, an average of 1 year

Change of muscle function (≤0.8 m / s)

次要结局

  • Physical activity(Baseline and through study completion, an average of 1 year)
  • Nutrition(Baseline and through study completion, an average of 1 year)
  • Risk of malnutrition(Baseline and through study completion, an average of 1 year)
  • height(Baseline and through study completion, an average of 1 year)
  • Sleep behaviour(Baseline and through study completion, an average of 1 year)
  • Weight(Baseline and through study completion, an average of 1 year)

研究者

发起方
University Rovira i Virgili
申办方类型
Other
责任方
Principal Investigator
主要研究者

Rosa Sola

MD, PhD. Full professor

University Rovira i Virgili

研究点 (1)

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