Protocol summary
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Study aim
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The effect of self-care mobile-based intervention on psychologic parameters of admitted patients with COVID-19
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Design
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A randomized, nonblinded, two-arm, parallel-group, phase 3 controlled trial on 112 patients.
www.randomization.com website was used for randomization.
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Settings and conduct
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This study will be conducted on 112 patients admitted to Imam Reza hospital in Mashhad who diagnosed with COVID-19
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Hospitalized patients with COVID- 19; patients who own a smartphone; patients who have the ability to work with a smartphone; at least 18 years old.
Exclusion criteria: Unwillingness to stay in the study; Transfer to wards where it is not possible to use a cellphone, such as the intensive care unit.
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Intervention groups
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This study consists of two groups. In addition to usual care, patients in the intervention group will receive a self-care smartphone application provided with the capability to educate patients, establish two-way interaction between patients and their attending physician, and psychological consultants. Patients in the control group will only receive usual care.
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Main outcome variables
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DASS-21 questionnaire score
General information
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Reason for update
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With the decrease in the number of patients with Covid-19 in Imam Reza hospital, the hospital was excluded from the coverage of corona-specific treatment. So, it was not possible to conduct the study. But with the increase in the number of patients in recent weeks, it was re-assigned to corona patients.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20170922036314N4
Registration date:
2020-06-22, 1399/04/02
Registration timing:
prospective
Last update:
2020-08-08, 1399/05/18
Update count:
1
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Registration date
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2020-06-22, 1399/04/02
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-07-10, 1399/04/20
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Expected recruitment end date
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2021-03-18, 1399/12/28
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Evaluating the effects of self-care mobile application on psychologic parameters of admitted patients with Covid-19: a randomized controlled trial
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Public title
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The effects of self-care cellphone application on stress, anxiety and depression among admitted patients with COVID-19
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
baseline literacy
having a smartphone
ability to work with smartphone
at least 3 days hospitalization
Exclusion criteria:
Unwillingness to participate in the study
Transfer to wards where it is not possible to use a mobile phone, such as the intensive care unit
Deterioration of the patient's physical condition
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Age
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From 18 years old to 65 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
112
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Method of randomization: simple randomization; Unit of randomization: individual randomization; the tool used in randomization: sealed envelops; the random sequence will be built using www.randomization.com website
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-04-19, 1399/01/31
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Ethics committee reference number
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IR.MUMS.REC.1399.118
Health conditions studied
1
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Description of health condition studied
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COVID-19
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ICD-10 code
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U07. 1
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ICD-10 code description
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COVID-19, virus identified
Primary outcomes
1
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Description
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DASS‐21 questionnaire score
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Timepoint
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Before intervention, at the time of discharge, 2 weeks after discharge
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Method of measurement
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DASS‐21 questionnaire score (including depression, anxiety, stress scales)
Secondary outcomes
1
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Description
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respiratory rate
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Timepoint
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Before intervention, at the time of discharge
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Method of measurement
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physician assessment
2
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Description
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oxygen saturation
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Timepoint
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Before intervention, at the time of discharge
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Method of measurement
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pulse oxymetry
3
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Description
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lung involvement
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Timepoint
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Before intervention, at the time of discharge
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Method of measurement
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radiography
4
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Description
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Multi-organ failure
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Timepoint
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Before intervention, at the time of discharge
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Method of measurement
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kidney and liver function tests
5
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Description
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fever
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Timepoint
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Before intervention, at the time of discharge
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Method of measurement
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thermometer
6
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Description
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secondary infection
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Timepoint
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Before intervention, at the time of discharge
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Method of measurement
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physician assessment
Intervention groups
1
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Description
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Intervention group: The intervention group will use a mobile-based application from the time of admission to two weeks after discharge. Educational material in the application required for patients with COVID-19 is provided using valid educational resources and experts' consensus. Also, patients can ask their questions from care providers through application and receive appropriate answers. Also, the patients can record their symptoms and thus their physician will be able to monitor and control their illness remotely.
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Category
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Behavior
2
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Description
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Control group: The control group will not receive intervention
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Category
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N/A
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Mashhad University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available