Smartphone Applications to Improve Lifestyles in Olders Over 65 Years

Telemedicine Clinical Trial

— EVIDENT-Age  

Official title:

Effectiveness of the Combined Use of Smartphone and Smartband Technology in the Improvement of Lifestyles in the Adult Population Over 65 Years of Age. Randomized Clinical Trial. EVIDENT Age Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03574480
• Other study ID #: YB17/00003
• Status: Completed
• Phase: N/A
• Start date: September 5, 2018
• Est. completion date: September 30, 2020

Study information

• Verified date: February 2020
• Source: Fundacion para la Investigacion y Formacion en Ciencias de la Salud
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a randomized controlled clinical trial performed in urban primary care centers in Salamanca (Spain). Its objective is to evaluate the effect of an intervention based on the use of new information and communication technologies in a population of people over 65 years of age in the improvement of lifestyles, body composition, quality of life, cognitive performance and daily life activities.

Description:

• Objective: To evaluate the effect of an intervention based on the use of new information and communication technologies in a population of people over 65 years of age.

• Design and setting: A randomized clinical trial of two parallel groups. Population: 140 participants over 65 years of age will be included, selected by consecutive sampling in primary care centers of Salamanca (Spain.

• Measurements and intervention: Lifestyles (physical activity, sedentarism and mediterranean diet), body composition, health-related quality of life, cognitive performance and daily life activities will be evaluated at 3 months. The advice on healthy diet and physical activity recommendations will be common to both groups. The intervention group will be added a training for 3 months in use of a Smartphone application, designed to promote a healthy diet, increased physical acivity and decreased sedentary.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: September 30, 2020
• Est. primary completion date: May 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 80 Years

Eligibility

Inclusion Criteria:

• Informed consent signed

• Age between 65 and 80 years

Exclusion Criteria:

• Cardiovascular disease

• Moderate or severe chronic obstructive pulmonary disease.

• Musculoskeletal disease that limits ambulation.

• Severe mental illness

• Score in the Mini-mental <24 points.

• Oncological disease in treatment.

Related Conditions & MeSH terms

• Telemedicine

Intervention

Behavioral:
• Intervention (training in use of a Smartphone application)
The intervention group will be added a training for 3 months in use of a Smartphone application, designed to promote a healthy diet, increased physical acivity and decreased sedentary.
• Control (Advice on healthy diet and physical activity recommendations)
Advice on healthy diet and physical activity recommendations

Locations

Country	Name	City	State
Spain	Instituto Biosanitario de Salamanca. Research Unit La Alamedilla	Salamanca

Sponsors (2)

Lead Sponsor	Collaborator
Fundacion para la Investigacion y Formacion en Ciencias de la Salud	Instituto de Investigación Biomédica de Salamanca

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical activity	Measurement by accelerometer (steps/day)	3 months
Secondary	Body composition	Measurement by Body fat percentage (%)	3 months
Secondary	Cognitive performance	Measurement by MINI MENTAL STATE EXAMINATION (Score between 0 (Cognitive impairment) and 30 (normal))	3 months
Secondary	Improve Quality of life	Measurement by the WHOQOL-AGE scale (Score between 13 (poor quality) and 65 (high quality))	3 months
Secondary	Daily life activities	Measurement by PFEFFER FUNCTIONAL ACTIVITY Questionnaire (Score between 0 (normal) and 33 (Functional alteration))	3 months
Secondary	Sedentarism	Measurement by Marshall questionnaire (sitting time - hours/day)	3 months
Secondary	Adherence to the Mediterranean Diet	Measurement by the MEDAS scale (Score between 0 (poor adherence) and 14 (high adherence))	3 months