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Completed

NCT Number: NCT04747132

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

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

Completed

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Key information

Conditions

Effectiveness COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad Iberoamericana

Mexico City, 01219, Mexico

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Telegeriatric intervention

Other

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

Other names: Telenutrition intervention

Primary outcomes

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

    Time frame: 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.

    Time frame: 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

    Time frame: 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.

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Universidad Iberoamericana A.C., Mexico

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Feb 10, 2021
Registry last updated
Feb 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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