NCT04747132

Brief Summary

The purpose of this studdy is to assess the effectiveness of a telegeriatric intervention

Trial Health

87
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2020

Shorter than P25 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

Study Start

First participant enrolled

July 20, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2020

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 16, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 6, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 10, 2021

Completed
Last Updated

February 10, 2021

Status Verified

February 1, 2021

Enrollment Period

3 months

First QC Date

February 6, 2021

Last Update Submit

February 8, 2021

Conditions

Keywords

AgedInternet-Based InterventionCOVID-19

Outcome Measures

Primary Outcomes (7)

  • Visual analog scale of the European quality of life questionnaire

    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.

    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

    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.

    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

    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

    It will be evaluated by using the SECA anthropometric tape Change from baseline to week 12

    Change from baseline to week 12

  • Dietary intake

    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

Study Arms (2)

Intervention group

EXPERIMENTAL

Individualized geriatric medical counseling, psychological counseling, nutritional counseling and physical activity counseling through the internet

Other: Telegeriatric intervention

Control group

NO INTERVENTION

Health guidance through standardized audiovisual educational material through Intenert

Interventions

Individualized, comprehensive and specialized counseling for older adults through the Internet

Also known as: Telenutrition intervention
Intervention group

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Iberoamericana

Mexico City, Mexico City, 01219, Mexico

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Rosas Carrasco

    Universidad Iberoamericana

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Investigator

Study Record Dates

First Submitted

February 6, 2021

First Posted

February 10, 2021

Study Start

July 20, 2020

Primary Completion

October 20, 2020

Study Completion

November 16, 2020

Last Updated

February 10, 2021

Record last verified: 2021-02

Locations