Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Telerehabilitation in Covid-19 After Hospital Discharge (TRCovidA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04742946
Recruitment Status : Not yet recruiting
First Posted : February 8, 2021
Last Update Posted : February 10, 2021
Sponsor:
Information provided by (Responsible Party):
Jose Manuel Pastora Bernal, Universidad de Granada

Brief Summary:
The COVID-19 can cause important sequels in the respiratory system by bilateral pneumonia and frequently presents loss of strength, dyspnea, polyneuropathies and multi-organic affectation. Physiotherapy interventions acquires a fundamental role in the recovery of the functions and the quality of life. Regarding the recovery phases after hospital discharge, both in patients with mild-moderate and severe-critical conditions, the currently evidence available are very preliminary. Telerehabilitation is presented as a promising complementary treatment method to standard physiotherapy. The main objective of this research is to evaluate the effectiveness of a personalized telerehabilitation intervention in patients diagnosed with Covid-19 after discharge from hospital for the improvement of functional capacity and quality of life compared to a program of health education and/or care in a rehabilitation center, which is the current standard procedure in the Health Service of the Junta de Andalucía (Spain). As secondary objectives, the aim is to identify the satisfaction and perception of patients with the telerehabilitation intervention and the presence of barriers to its implementation, as well as to evaluate the cost-effectiveness from the perspective of the health system. This research will be carried out through a single blind multicenter randomized clinical trial in patients residing in Andalucía (Spain). The hypothesis of this research is that the implementation of a Telerehabilitation program presents results not inferior than those obtained with the current standard intervention. If hypothesis is confirmed, that would be an opportunity to define new policies and interventions to address this disease and its consequences.

Condition or disease Intervention/treatment Phase
Covid19 Other: Standard Physiotherapy program Other: Telerehabilitation Not Applicable

Detailed Description:
The hypothesis of this research is that the implementation of a Telerehabilitation program in patients with Covid-19 presents results not inferior than those obtained with the current standard intervention. If hypothesis is confirmed, that would be an opportunity to define new policies and interventions to address this disease and its consequences.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 237 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Telerehabilitation Intervention in Patients With Covid-19 After Hospital Discharge to Improve Functional Capacity and Quality of Life. Study Protocol for a Multicenter Randomized Clinical Trial
Estimated Study Start Date : February 15, 2021
Estimated Primary Completion Date : May 30, 2021
Estimated Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: TR Group
Personalized Telerehabilitation program during 8 weeks. One session per day. Web and mobile application
Other: Telerehabilitation
Online Physiotherapy services
Other Name: Telemedicine, ehealth

Active Comparator: Control Group
Standard of care. Rehabilitation program in their hospital or primary care or a health education program to be carried out at home.
Other: Standard Physiotherapy program
Respiratory and Standard Physiotherapy
Other Name: Physiotherapy




Primary Outcome Measures :
  1. Functional Capacity [ Time Frame: Baseline (T0) ]
    sit-to-stand test in 1 minute

  2. Functional Capacity [ Time Frame: 4 weeks (T1) ]
    sit-to-stand test in 1 minute

  3. Functional Capacity [ Time Frame: 8 weeks (T1) ]
    sit-to-stand test in 1 minute

  4. Functional Capacity (SPBB) short performance physical battery test [ Time Frame: Baseline (T0) ]
    (SPBB) short performance physical battery test

  5. Functional Capacity (SPBB) short performance physical battery test [ Time Frame: Baseline 4 weeks (T1) ]
    (SPBB) short performance physical battery test

  6. Functional Capacity (SPBB) short performance physical battery test [ Time Frame: Baseline 8 weeks (T2) ]
    (SPBB) short performance physical battery test

  7. The Short Form Health Survey SF-12 [ Time Frame: Baseline (T0) ]

    Quality of Live. For each of the 8 dimensions, the items are coded, aggregated and transformed into a scale ranging from 0 (the worst health status for that dimension) to 0 (the worst health status for that dimension).

    a scale ranging from 0 (the worst health status for that dimension) to 100 (the best health status).

    100 (the best health status)


  8. The Short Form Health Survey SF-12 Quality of Live [ Time Frame: 4 weeks (T1) ]

    The SF-12 For each of the 8 dimensions, the items are coded, aggregated and transformed into a scale ranging from 0 (the worst health status for that dimension) to 0 (the worst health status for that dimension).

    a scale ranging from 0 (the worst health status for that dimension) to 100 (the best health status).

    100 (the best health status)


  9. The Short Form Health Survey SF-12 Quality of Live [ Time Frame: 8 weeks (T1) ]

    The SF-12 For each of the 8 dimensions, the items are coded, aggregated and transformed into a scale ranging from 0 (the worst health status for that dimension) to 0 (the worst health status for that dimension).

    a scale ranging from 0 (the worst health status for that dimension) to 100 (the best health status).

    100 (the best health status)


  10. European Quality of Life-5 Dimensions EQ-5D [ Time Frame: Baseline (T0) ]
    Quality of Live The responses to the five EQ-5D dimensions (i.e. an EQ-5D health state or profile) can be converted into a single number called an index value. The index value reflects how good or bad the health state is according to the preferences of the general population of a country/region. The collection of index values for all possible EQ-5D states is called a value set. Value sets are currently available for the EQ-5D-3L and EQ-5D-5L for different countries/regions. Several valuation techniques have been used to generate these value sets: time trade-off (TTO), visual analogue scale (VAS), and more recently, discrete choice experiments (DCE).

  11. European Quality of Life-5 Dimensions EQ-5D [ Time Frame: 4 weeks (T1) ]
    Quality of Live The responses to the five EQ-5D dimensions (i.e. an EQ-5D health state or profile) can be converted into a single number called an index value. The index value reflects how good or bad the health state is according to the preferences of the general population of a country/region. The collection of index values for all possible EQ-5D states is called a value set. Value sets are currently available for the EQ-5D-3L and EQ-5D-5L for different countries/regions. Several valuation techniques have been used to generate these value sets: time trade-off (TTO), visual analogue scale (VAS), and more recently, discrete choice experiments (DCE).

  12. European Quality of Life-5 Dimensions EQ-5D [ Time Frame: 8 weeks (T2) ]
    Quality of Live The responses to the five EQ-5D dimensions (i.e. an EQ-5D health state or profile) can be converted into a single number called an index value. The index value reflects how good or bad the health state is according to the preferences of the general population of a country/region. The collection of index values for all possible EQ-5D states is called a value set. Value sets are currently available for the EQ-5D-3L and EQ-5D-5L for different countries/regions. Several valuation techniques have been used to generate these value sets: time trade-off (TTO), visual analogue scale (VAS), and more recently, discrete choice experiments (DCE).


Secondary Outcome Measures :
  1. Telemedicine Satisfaction and Usefulness Questionnaire (TSUQ) [ Time Frame: 4 weeks (T1) ]
    Telemedicine Satisfaction and Usefulness Questionnaire (TSUQ). Perceived usefulness, perceived effectiveness, perceived ease of use, attitude, intention to use, comparing telemedicine to inperson in 26 Questions with likert scales

  2. Telemedicine Satisfaction and Usefulness Questionnaire (TSUQ) [ Time Frame: 8 weeks (T2) ]
    Telemedicine Satisfaction and Usefulness Questionnaire (TSUQ). Perceived usefulness, perceived effectiveness, perceived ease of use, attitude, intention to use, comparing telemedicine to inperson in 26 Questions with likert scales

  3. Cost-effectiveness of the telerehabilitation intervention [ Time Frame: 4 weeks T1 ]
    Direct Costs

  4. Cost-effectiveness of the telerehabilitation intervention [ Time Frame: 8 weeks T2 ]
    Direct Costs



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adult over 18 years old
  • Diagnosis: COVID-19 (Mild-Moderate, Severe-Critical
  • Residing in the Andalusian Community during the research period
  • To have a computer technology with an internet connection aat home (personal computer, laptop, tablet or smartphone)
  • Ability and knowledge to access email or whatsapp

Exclusion Criteria:

-Cognitive ability not suitable for the use of technological tools


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04742946


Contacts
Layout table for location contacts
Contact: Jose-Manuel Pastora-Bernal, PhD 658561622 gruporehab@gmail.com

Locations
Layout table for location information
Spain
Facultad Ciencias de la Salud
Melilla, Spain, 29640
Sponsors and Collaborators
Universidad de Granada
Investigators
Layout table for investigator information
Principal Investigator: José-Manuel Pastora-Bernal, PhD Universidad de Granada
Additional Information:
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Jose Manuel Pastora Bernal, Principal Investigator, Universidad de Granada
ClinicalTrials.gov Identifier: NCT04742946    
Other Study ID Numbers: TRCovidAndalucía
First Posted: February 8, 2021    Key Record Dates
Last Update Posted: February 10, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Study protocol, Statistical Analysis plan and outcomes measures will be shared
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: 8 weeks
Access Criteria: data will be shared upon request to the principal investigator
URL: https://www.researchgate.net/profile/Jose_Manuel_Pastora_Bernal

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jose Manuel Pastora Bernal, Universidad de Granada:
Telerehabilitation
Covid19 sequelae
Additional relevant MeSH terms:
Layout table for MeSH terms
COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases