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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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)
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

Other trials in Spain

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 groups in NCT03574480
Study groupRoleWhat they receive
ControlExperimentalAdvice on healthy diet and physical activity recommendations
Receives: Behavioral: Control (Advice on healthy diet and physical activity recommendations)
InterventionExperimental* 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.

  1. Physical activity

    Measurement by accelerometer (steps/day)

    Measured: 3 months

Secondary outcomes (6)

  1. Body composition

    Measurement by Body fat percentage (%)

    Measured: 3 months

  2. Cognitive performance

    Measurement by MINI MENTAL STATE EXAMINATION (Score between 0 (Cognitive impairment) and 30 (normal))

    Measured: 3 months

  3. Improve Quality of life

    Measurement by the WHOQOL-AGE scale (Score between 13 (poor quality) and 65 (high quality))

    Measured: 3 months

  4. Daily life activities

    Measurement by PFEFFER FUNCTIONAL ACTIVITY Questionnaire (Score between 0 (normal) and 33 (Functional alteration))

    Measured: 3 months

  5. Sedentarism

    Measurement by Marshall questionnaire (sitting time - hours/day)

    Measured: 3 months

  6. 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.

  1. First posted2 Jul 2018
  2. Study start5 Sep 2018
  3. Primary completion31 May 2020
  4. Study completion30 Sep 2020

Resources

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)
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 36203135

  • Recio-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

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.

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