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

Sponsor
Universidad Iberoamericana A.C., Mexico (Other)
Overall Status
Completed
CT.gov ID
NCT04747132
Collaborator
(none)
110
1
2
3.9
28.1

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: Telegeriatric intervention
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
110 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Health Services Research
Official Title:
Effectiveness of a Telegeriatric Intervention in Older Adults During the Covid-19 Contingency
Actual Study Start Date :
Jul 20, 2020
Actual Primary Completion Date :
Oct 20, 2020
Actual Study Completion Date :
Nov 16, 2020

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. Visual analog scale of the European quality of life questionnaire [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

    2. Physical performance. [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

    3. Depressive symptoms [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

    4. Symptoms of anxiety. [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

    5. Body composition [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

    6. Anthropometric measures [Change from baseline to week 12]

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

    7. Dietary intake [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Universidad Iberoamericana Ciudad de Mexico Ciudad De México Mexico 01219

    Sponsors and Collaborators

    • Universidad Iberoamericana A.C., Mexico

    Investigators

    • Principal Investigator: Rosas Carrasco, Universidad Iberoamericana

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Oscar Rosas Carrasco, Investigator, Universidad Iberoamericana A.C., Mexico
    ClinicalTrials.gov Identifier:
    NCT04747132
    Other Study ID Numbers:
    • SALUD-2021-Telegeria
    First Posted:
    Feb 10, 2021
    Last Update Posted:
    Feb 10, 2021
    Last Verified:
    Feb 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Oscar Rosas Carrasco, Investigator, Universidad Iberoamericana A.C., Mexico
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 10, 2021