Telemedicine Clinical Trial
— EVIDENT-AgeOfficial 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
Verified date | February 2020 |
Source | Fundacion para la Investigacion y Formacion en Ciencias de la Salud |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Spain | Instituto Biosanitario de Salamanca. Research Unit La Alamedilla | Salamanca |
Lead Sponsor | Collaborator |
---|---|
Fundacion para la Investigacion y Formacion en Ciencias de la Salud | Instituto de Investigación Biomédica de Salamanca |
Spain,
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 |
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