Earlier Elderly People in Rural Areas

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

Study Overview

• Status: Recruiting
• Conditions: Physical Activity; Sleep; Sarcopenia; Health Behavior; Nutrition; Lifestyle, Healthy
• Intervention / Treatment: Behavioral: Citizen Science intervention

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.

• Study Type: Interventional
• Enrollment (Anticipated): 176
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rosa Solà, Dr; Phone Number: 0034 977759369; Email: rosa.sola@urv.cat
• Study Contact Backup: Name: Lucia Tarro, Dr; Phone Number: 0034 977758920; Email: lucia.tarro@urv.cat

Study Locations

• Spain
  • Tarragona
    • Reus, Tarragona, Spain
      • Recruiting
      • University Rovira i Virgili

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Citizen Science Behavioral Intervention; 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.	Behavioral: Citizen Science intervention; Intervention generated by a participatory research process (co-creation) in the elderly population living in rural areas to co-create solutions to improve their lifestyles, quality of life and health.
No Intervention: Control group; The controls group (CG) participants will not receive any kind of intervention, and participants will only be assessed at baseline and end-of-study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Risk of sarcopenia (muscle strength)	Change of muscle strength: <27kg in men and <16kg in women measured by a dynamometer	Baseline and through study completion, an average of 1 year
Diagnosis of sarcopenia (muscle strength)	Change of muscle strength (<27kg in men and <16kg in women measured by a dynamometer)	Baseline and through study completion, an average of 1 year
Diagnosis of sarcopenia (muscle mass)	Change of muscle mass (<20kg in men and <15kg in women measured by bioimpedance)	Baseline and through study completion, an average of 1 year
Diagnosis of severe sarcopenia (muscle strength)	Change of muscle strength (<27kg in men and <16kg in women measured by a dynamometer)	Baseline and through study completion, an average of 1 year
Diagnosis of severe sarcopenia (muscle mass)	Change of muscle mass (<20kg in men and <15kg in women measured by bioimpedance)	Baseline and through study completion, an average of 1 year
Diagnosis of severe sarcopenia (muscle function)	Change of muscle function (≤0.8 m / s)	Baseline and through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nutrition	Food frequency questionnaire (not scale)	Baseline and through study completion, an average of 1 year
Physical activity	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).	Baseline and through study completion, an average of 1 year
Sleep behaviour	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.	Baseline and through study completion, an average of 1 year
Risk of malnutrition	Mini Nutritional Assessment 12-14 points: normal nutritional status 8-11 points: risk of malnutrition 0-7 points: malnutrition	Baseline and through study completion, an average of 1 year
Weight	Weight using a balance	Baseline and through study completion, an average of 1 year
height	Height using a tallimeter	Baseline and through study completion, an average of 1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age	Age in years	Baseline and through study completion, an average of 1 year
Gender	Female or male	Baseline

Collaborators and Investigators

• Sponsor: University Rovira i Virgili

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Anticipated): May 15, 2022
• Study Completion (Anticipated): December 30, 2023

Study Registration Dates

• First Submitted: February 17, 2022
• First Submitted That Met QC Criteria: February 28, 2022
• First Posted (Actual): March 10, 2022

Study Record Updates

• Last Update Posted (Actual): March 31, 2022
• Last Update Submitted That Met QC Criteria: March 15, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Sarcopenia
• Other Study ID Numbers: Earlier-Elderly Rural People

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No