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

Effectiveness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04747132
• Other study ID #: SALUD-2021-Telegeria
• Status: Completed
• Phase: N/A
• Start date: July 20, 2020
• Est. completion date: November 16, 2020

Study information

• Verified date: February 2021
• Source: Universidad Iberoamericana A.C., Mexico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: November 16, 2020
• Est. primary completion date: October 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Effectiveness

Intervention

Other:
• Telegeriatric intervention
Individualized, comprehensive and specialized counseling for older adults through the Internet

Locations

Country	Name	City	State
Mexico	Universidad Iberoamericana	Ciudad de Mexico	Ciudad De México

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Iberoamericana A.C., Mexico

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Anthropometric measures	It will be evaluated by using the SECA anthropometric tape Change from baseline to week 12	Change from baseline to week 12
Primary	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