NCT03574480

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 20, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 2, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

September 5, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
Last Updated

November 15, 2022

Status Verified

February 1, 2020

Enrollment Period

1.7 years

First QC Date

June 20, 2018

Last Update Submit

November 13, 2022

Conditions

Telemedicine

Keywords

mHealthLifestylesElderlyBody compositionCognitive performanceQuality of life

Outcome Measures

Primary Outcomes (1)

  • Physical activity

    Measurement by accelerometer (steps/day)

    3 months

Secondary Outcomes (6)

  • Body composition

    3 months

  • Cognitive performance

    3 months

  • Improve Quality of life

    3 months

  • Daily life activities

    3 months

  • Sedentarism

    3 months

  • +1 more secondary outcomes

Study Arms (2)

Control

EXPERIMENTAL

Advice on healthy diet and physical activity recommendations

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.

Behavioral: Intervention (training in use of a Smartphone application)Behavioral: Control (Advice on healthy diet and physical activity recommendations)

Interventions

Intervention (training in use of a Smartphone application)BEHAVIORAL

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.

Intervention
Control (Advice on healthy diet and physical activity recommendations)BEHAVIORAL

Advice on healthy diet and physical activity recommendations

ControlIntervention

Eligibility Criteria

Age65 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Informed consent signed
  • Age between 65 and 80 years

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Biosanitario de Salamanca. Research Unit La Alamedilla

Salamanca, 37003, Spain

Location

Related Publications (2)

  • 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.

    PMID: 36203135DERIVED

  • 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.

    PMID: 30674284DERIVED

MeSH Terms

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Jose I Recio-Rodriguez, PhD

    University of Salamanca

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2018

First Posted

July 2, 2018

Study Start

September 5, 2018

Primary Completion

May 31, 2020

Study Completion

September 30, 2020

Last Updated

November 15, 2022

Record last verified: 2020-02

Locations

ES(1)