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

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

Mexico

Study Type

Interventional

Intervention

Telegeriatric intervention

About this trial

This is an interventional health services research trial for Effectiveness focused on measuring Aged, Internet-Based Intervention, COVID-19

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Universidad Iberoamericana

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control group

Arm Description

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

Health guidance through standardized audiovisual educational material through Intenert

Outcomes

Primary Outcome Measures

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

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

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

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

Body composition

It will be evaluated by using the OMROM HBF-514C® 50 Hz portable electrical bioimpedance bascule Change from baseline to week 12

Anthropometric measures

It will be evaluated by using the SECA anthropometric tape 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

Secondary Outcome Measures

Full Information

NCT ID

NCT04747132

First Posted

February 6, 2021

Last Updated

February 8, 2021

Sponsor

Universidad Iberoamericana A.C., Mexico

1. Study Identification

Unique Protocol Identification Number

NCT04747132

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Completed

Study Start Date

July 20, 2020 (Actual)

Primary Completion Date

October 20, 2020 (Actual)

Study Completion Date

November 16, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Universidad Iberoamericana A.C., Mexico

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

Brief Summary

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

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Effectiveness

Keywords

Aged, Internet-Based Intervention, COVID-19

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

110 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intervention group

Arm Type

Experimental

Arm Description

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

Arm Title

Control group

Arm Type

No Intervention

Arm Description

Health guidance through standardized audiovisual educational material through Intenert

Intervention Type

Other

Intervention Name(s)

Telegeriatric intervention

Other Intervention Name(s)

Telenutrition intervention

Intervention Description

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

Primary Outcome Measure Information:

Title

Visual analog scale of the European quality of life questionnaire

Description

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

Time Frame