Effectiveness of a Telegeriatric Intervention in Older Adults During the Covid-19 Contingency
Primary Purpose
Effectiveness
Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Telegeriatric intervention
Sponsored by
About this trial
This is an interventional health services research trial for Effectiveness focused on measuring Aged, Internet-Based Intervention, COVID-19
Eligibility Criteria
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
Change from baseline to week 12
Title
Physical performance.
Description
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
Time Frame
Change from baseline to week 12
Title
Depressive symptoms
Description
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
Time Frame
Change from baseline to week 12
Title
Symptoms of anxiety.
Description
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
Time Frame
Change from baseline to week 12
Title
Body composition
Description
It will be evaluated by using the OMROM HBF-514C® 50 Hz portable electrical bioimpedance bascule Change from baseline to week 12
Time Frame
Change from baseline to week 12
Title
Anthropometric measures
Description
It will be evaluated by using the SECA anthropometric tape Change from baseline to week 12
Time Frame
Change from baseline to week 12
Title
Dietary intake
Description
It will be evaluated by using the ASA24 software for 24-hour reminder collection by multiple steps.
Change from baseline to week 12
Time Frame
Change from baseline to week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rosas Carrasco
Organizational Affiliation
Universidad Iberoamericana
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidad Iberoamericana
City
Ciudad de Mexico
State/Province
Ciudad De México
ZIP/Postal Code
01219
Country
Mexico
12. IPD Sharing Statement
Learn more about this trial
Effectiveness of a Telegeriatric Intervention in Older Adults During the Covid-19 Contingency
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