Effectiveness of a Telegeriatric Intervention in Older Adults During the Covid-19 Contingency

February 8, 2021 updated by: Oscar Rosas Carrasco, Universidad Iberoamericana A.C., Mexico
The purpose of this studdy is to assess the effectiveness of a telegeriatric intervention

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The patients were recruited from a cohort study in which the participants had previously signed an informed consent in which they allowed contact to participate in new studies, participants who met the inclusion criteria in the original database were recruited and signed an electronic informed consent of the new study. A comprehensive geriatric assessment was generated to assess whether they were candidates even due to changes in health status that could change over time since their last assessment, they were recruited until the expected sample size was obtained, and they were randomized, blinding the participants to belong to the intervention group (individualized care: geriatrics, psychology, physical activity and nutrition) or the control group (orientation in standardized health issues through audiovisual educational material)

Study Type

Interventional

Enrollment (Actual)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Ciudad De México
      • Ciudad de Mexico, Ciudad De México, Mexico, 01219
        • Universidad Iberoamericana

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adults 60 years and over
  • Who agree to participate in the study.

Exclusion Criteria:

  • Older adults who are in a systematic exercise program or directed food restriction programs
  • Physical, sensory or cognitive disabilities that prevent exercise, includes Mini Mental State Examination less than 20 points of the total score
  • Any condition acute or chronic health conditions that clinical staff judge as an impediment to the exercise program or remote monitoring
  • Recent major or limb surgery
  • Orthopedic conditions that would impede the exercise program
  • Any problem swallowing
  • Previous mental disorders such as disorder and schizophrenia
  • Not having personal access to the WhatsApp application via video call.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
Individualized geriatric medical counseling, psychological counseling, nutritional counseling and physical activity counseling through the internet
Other: Telegeriatric intervention
Individualized, comprehensive and specialized counseling for older adults through the Internet
Other Names:
  • Telenutrition intervention
No Intervention: Control group
Health guidance through standardized audiovisual educational material through Intenert

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual analog scale of the European quality of life questionnaire
Time Frame: Change from baseline to week 12
The visual analog scale of the European quality of life questionnaire, adapted and validated to Spanish, Mexico (EQ5D-VAS) will be used. Which consists of a visual analog scale, its total score ranges from 0 to 100 points, the higher the score, the better the quality of life, it will be considered as a continuous quantitative variable. (Juárez-Cedillo T et al., 2015) Change from baseline to week 12
Change from baseline to week 12
Physical performance.
Time Frame: Change from baseline to week 12
It will be evaluated through the short physical performance test (SPPB), which is a test that includes three dimensions: strength. March and balance, your score ranges from 0 to 12 points, the higher the score the better the physical performance, it will be considered as a continuous quantitative variable. (Guralnik JM et al., 1989) Change from baseline to week 12
Change from baseline to week 12
Depressive symptoms
Time Frame: Change from baseline to week 12
It will be evaluated using the CESD scale 7 items validated into Spanish in Mexico. His score ranges from 0 to 21 points, the higher the score, the greater the depressive symptoms. The total score will be considered as a continuous quantitative variable. (Salinas-Rodríguez A et al., 2014) Change from baseline to week 12
Change from baseline to week 12
Symptoms of anxiety.
Time Frame: Change from baseline to week 12
It will be evaluated through the geriatric anxiety inventory, which is validated in Spanish, consists of 20 dichotomous items, its total score ranges from 0 to 20, the higher the score, the greater the anxiety symptoms. It will be considered as a continuous quantitative variable. (Márquez-González M et al., 2012) Change from baseline to week 12
Change from baseline to week 12
Body composition
Time Frame: Change from baseline to week 12
It will be evaluated by using the OMROM HBF-514C® 50 Hz portable electrical bioimpedance bascule Change from baseline to week 12
Change from baseline to week 12
Anthropometric measures
Time Frame: Change from baseline to week 12
It will be evaluated by using the SECA anthropometric tape Change from baseline to week 12
Change from baseline to week 12
Dietary intake
Time Frame: Change from baseline to week 12

It will be evaluated by using the ASA24 software for 24-hour reminder collection by multiple steps.

Change from baseline to week 12
Change from baseline to week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Iberoamericana A.C., Mexico

Investigators

  • Principal Investigator: Rosas Carrasco, Universidad Iberoamericana

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 20, 2020

Primary Completion (Actual)

October 20, 2020

Study Completion (Actual)

November 16, 2020

Study Registration Dates

First Submitted

February 6, 2021

First Submitted That Met QC Criteria

February 8, 2021

First Posted (Actual)

February 10, 2021

Study Record Updates

Last Update Posted (Actual)

February 10, 2021

Last Update Submitted That Met QC Criteria

February 8, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SALUD-2021-Telegeria

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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