Clinical trial NCT05273502: Earlier Elderly People in Rural Areas
Official title: Characterization, Creativity, Leadership, and Search for Solutions to Improve the Lifestyles of Earlier Elderly People in Rural Areas
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Health Behavior
Sarcopenia
Nutrition
Sleep
Physical Activity
Lifestyle, Healthy
Lead sponsor: University Rovira i Virgili
Sponsor class: OTHER
First posted: 2022-03-10
Enrollment: 176
Sex: ALL
Minimum age (years): 60
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial (cluster)
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

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

Primary outcomes:
measure: Risk of sarcopenia (muscle strength)
timeFrame: Baseline and through study completion, an average of 1 year
measure: Diagnosis of sarcopenia (muscle strength)
timeFrame: Baseline and through study completion, an average of 1 year
measure: Diagnosis of sarcopenia (muscle mass)
timeFrame: Baseline and through study completion, an average of 1 year
measure: Diagnosis of severe sarcopenia (muscle strength)
timeFrame: Baseline and through study completion, an average of 1 year
measure: Diagnosis of severe sarcopenia (muscle mass)
timeFrame: Baseline and through study completion, an average of 1 year
measure: Diagnosis of severe sarcopenia (muscle function)
timeFrame: Baseline and through study completion, an average of 1 year
Secondary outcomes:
measure: Nutrition
timeFrame: Baseline and through study completion, an average of 1 year
measure: Physical activity
timeFrame: Baseline and through study completion, an average of 1 year
measure: Sleep behaviour
timeFrame: Baseline and through study completion, an average of 1 year
measure: Risk of malnutrition
timeFrame: Baseline and through study completion, an average of 1 year
measure: Weight
timeFrame: Baseline and through study completion, an average of 1 year
measure: height
timeFrame: Baseline and through study completion, an average of 1 year
Other outcomes:
measure: Age
timeFrame: Baseline and through study completion, an average of 1 year
measure: Gender
timeFrame: Baseline
Locations:
city: Reus
country: Spain
facility: University Rovira i Virgili
state: Tarragona
Study officials:
References: