TelemedicineEVIDENT-AgeNCT03574480
Smartphone Applications to Improve Lifestyles in Olders Over 65 Years
A study testing Intervention (training in use of a Smartphone application) in people with Telemedicine, run by Fundacion para la Investigacion y Formacion en Ciencias de la Salud at 1 site in Spain.
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… Read more about this study
- Who is it for?
- Ages 65 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Telemedicine
- What is being tested?
- Intervention (training in use of a Smartphone application)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteSpain
- Study dates
- 5 Sep 2018to 30 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 80 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Informed consent signed
- Age between 65 and 80 years
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Instituto Biosanitario de Salamanca. Research Unit La Alamedilla
Salamanca, 37003
About this study
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
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.
Read the detailed 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.
- Conditions
- Telemedicine
- Being tested
- Intervention (training in use of a Smartphone application), Control (Advice on healthy diet and physical activity recommendations)
- Keywords
- mHealth, Lifestyles, Elderly, Body composition, Cognitive performance, Quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention (training in use of a Smartphone application)Behavioural
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)Behavioural
Advice on healthy diet and physical activity recommendations
| Study group | Role | What they receive |
|---|---|---|
| Control | Experimental | Advice on healthy diet and physical activity recommendations Receives: Behavioral: Control (Advice on healthy diet and physical activity recommendations) |
| Intervention | Experimental | * Advice on healthy diet and physical activity recommendations
* Training for 3 months in use of a Smartphone application, designed to promote a healthy diet, increased physical acivity and decreased sedentary. Receives: Behavioral: Intervention (training in use of a Smartphone application); Behavioral: Control (Advice on healthy diet and physical activity recommendations) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity
Measurement by accelerometer (steps/day)
Measured: 3 months
Secondary outcomes (6)
Body composition
Measurement by Body fat percentage (%)
Measured: 3 months
Cognitive performance
Measurement by MINI MENTAL STATE EXAMINATION (Score between 0 (Cognitive impairment) and 30 (normal))
Measured: 3 months
Improve Quality of life
Measurement by the WHOQOL-AGE scale (Score between 13 (poor quality) and 65 (high quality))
Measured: 3 months
Daily life activities
Measurement by PFEFFER FUNCTIONAL ACTIVITY Questionnaire (Score between 0 (normal) and 33 (Functional alteration))
Measured: 3 months
Sedentarism
Measurement by Marshall questionnaire (sitting time - hours/day)
Measured: 3 months
Adherence to the Mediterranean Diet
Measurement by the MEDAS scale (Score between 0 (poor adherence) and 14 (high adherence))
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2018
- Study start5 Sep 2018
- Primary completion31 May 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for TelemedicineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion para la Investigacion y Formacion en Ciencias de la Salud
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Investigación Biomédica de Salamanca
- Responsible party
- Sponsor
- Investigators
- Jose I Recio-Rodriguez, PhD, Principal investigator, University of Salamanca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03574480
- Sponsor's protocol ID
- YB17/00003
- Acronym
- EVIDENT-Age
- Status last verified
- Feb 2020
- First submitted
- 20 Jun 2018
- Last updated
- 15 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Recio-Rodriguez JI, Gonzalez-Sanchez S, Tamayo-Morales O, Gomez-Marcos MA, Garcia-Ortiz L, Nino-Martin V, Lugones-Sanchez C, Rodriguez-Sanchez E. Changes in lifestyles, cognitive impairment, quality of life and activity day living after combined use of smartphone and smartband technology: a randomized clinical trial (EVIDENT-Age study). BMC Geriatr. 2022 Oct 6;22(1):782. doi: 10.1186/s12877-022-03487-5.
PubMed 36203135Recio-Rodriguez JI, Lugones-Sanchez C, Agudo-Conde C, Gonzalez-Sanchez J, Tamayo-Morales O, Gonzalez-Sanchez S, Fernandez-Alonso C, Maderuelo-Fernandez JA, Mora-Simon S, Gomez-Marcos MA, Rodriguez-Sanchez E, Garcia-Ortiz L. Combined use of smartphone and smartband technology in the improvement of lifestyles in the adult population over 65 years: study protocol for a randomized clinical trial (EVIDENT-Age study). BMC Geriatr. 2019 Jan 23;19(1):19. doi: 10.1186/s12877-019-1037-y.
PubMed 30674284
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03574480
- Acronym / sponsor ID
- EVIDENT-Age / YB17/00003
- Conditions
- Telemedicine
- Keywords
- mHealth, Lifestyles, Elderly, Body composition, Cognitive performance, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Fundacion para la Investigacion y Formacion en Ciencias de la SaludUniversity, hospital or other
- Collaborators
- Instituto de Investigación Biomédica de Salamanca
- Study start
- 5 Sep 2018 (actual)
- Primary completion
- 31 May 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 2 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Experimental | Behavioral: Control (Advice on healthy diet and physical activity recommendations)Advice on healthy diet and physical activity recommendations |
| Intervention | Experimental | Behavioral: Intervention (training in use of a Smartphone application), Behavioral: Control (Advice on healthy diet and physical activity recommendations)* Advice on healthy diet and physical activity recommendations * Training for 3 months in use of a Smartphone application, designed to promote a healthy diet, increased physical acivity and decreased sedentary. |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Informed consent signed
- Age between 65 and 80 years
Key exclusion criteria (6 listed)
- Cardiovascular disease
- Moderate or severe chronic obstructive pulmonary disease.
- Musculoskeletal disease that limits ambulation.
- Severe mental illness
- Score in the Mini-mental <24 points.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Intervention |
| Control (Advice on healthy diet and physical activity recommendations)Advice on healthy diet and physical activity recommendations | Behavioural | Control, Intervention |
Primary outcome
Physical activity
Time frame: 3 months
Measurement by accelerometer (steps/day)
6 secondary outcomes
Body composition
Time frame: 3 months
Cognitive performance
Time frame: 3 months
Improve Quality of life
Time frame: 3 months
Daily life activities
Time frame: 3 months
Sedentarism
Time frame: 3 months
Adherence to the Mediterranean Diet
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2022.
- Derived from this study: PubMed 36203135Recio-Rodriguez JI, Gonzalez-Sanchez S, Tamayo-Morales O, Gomez-Marcos MA, Garcia-Ortiz L, Nino-Martin V, Lugones-Sanchez C, Rodriguez-Sanchez E. Changes in lifestyles, cognitive impairment, quality of life and activity day living after combined use of smartphone and smartband technology: a randomized clinical trial (EVIDENT-Age study). BMC Geriatr. 2022 Oct 6;22(1):782. doi: 10.1186/s12877-022-03487-5.
- Derived from this study: PubMed 30674284Recio-Rodriguez JI, Lugones-Sanchez C, Agudo-Conde C, Gonzalez-Sanchez J, Tamayo-Morales O, Gonzalez-Sanchez S, Fernandez-Alonso C, Maderuelo-Fernandez JA, Mora-Simon S, Gomez-Marcos MA, Rodriguez-Sanchez E, Garcia-Ortiz L. Combined use of smartphone and smartband technology in the improvement of lifestyles in the adult population over 65 years: study protocol for a randomized clinical trial (EVIDENT-Age study). BMC Geriatr. 2019 Jan 23;19(1):19. doi: 10.1186/s12877-019-1037-y.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose I Recio-Rodriguez, PhD principal investigator
University of Salamanca
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention (training in use of a Smartphone application) in people with Telemedicine, run by Fundacion para la Investigacion y Formacion en Ciencias de la Salud at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical activity (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03574480, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2022.