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Self-care App for Family Members of ICU Patients.

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04316767
Recruitment Status : Unknown
Verified August 2020 by Amy Petrinec, Kent State University.
Recruitment status was:  Recruiting
First Posted : March 20, 2020
Last Update Posted : September 2, 2020
Sponsor:
Collaborator:
Summa Health System
Information provided by (Responsible Party):
Amy Petrinec, Kent State University

Brief Summary:
Family members of critically ill (ICU) patients are at risk for developing significant symptoms of anxiety, depression, and post-traumatic stress during and after the ICU experience. Cognitive behavioral therapy is a form of therapy that can help individuals cope with stressful events in a more active and effective way. This study will examine the effectiveness of a smartphone self-care app delivering cognitive behavioral therapy in decreasing the psychological symptoms suffered by ICU family members. Half of the sample will receive the self-care app and half of the study sample will receive the usual supportive care given to family members of ICU patients. The researchers anticipate the self-care app will diminish the severity of anxiety, depression, and post-traumatic stress symptoms experienced by ICU family members.

Condition or disease Intervention/treatment Phase
Post Intensive Care Unit Syndrome Behavioral: App Intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A prospective, repeated measures, longitudinal design with randomization to one of two parallel groups (control, intervention) will be employed. Participants will be randomized to group assignment after study enrollment is completed and baseline measurements are obtained.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Smartphone Delivery of Cognitive Behavioral Therapy for Post-intensive Care Syndrome-Family: A Pilot Study
Actual Study Start Date : August 28, 2020
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: App Intervention
Participants will download a mobile self-care app on their smartphones. The app guides users through exercises based on cognitive behavioral therapy principles. Participants will be able to use the app as frequently as desired throughout the course of the study.
Behavioral: App Intervention
Participants will receive access to a self-care app for use on their smartphone. The app provides a suite of tools based on cognitive behavioral therapy and mindfulness. The app guides users through a variety of short lessons (3-5 minutes) that teach users to self-manage stress, mood, anxiety, and depression. Participants will be encouraged to use the app on a daily basis and will be able to use the app at their discretion.
Other Name: Sanvello app

No Intervention: Control
Participants will receive usual supportive care provided to family members of ICU patients.



Primary Outcome Measures :
  1. Change in anxiety-Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Baseline, 30 days, 60 days ]
    The HADS is a 14-item self-report scale with seven items forming an anxiety subscale (HADS-A) and seven items forming a depression subscale (HADS-D). Each of the two subscales can have scores ranging from 0-21 with higher scores indicating higher levels of anxiety or depression symptoms.

  2. Change in depression-Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Baseline, 30 days, 60 days ]
    The HADS is a 14-item scale with seven items forming an anxiety subscale (HADS-A) and seven items forming a depression subscale (HADS-D). Each of the two subscales can have scores ranging from 0-21 with higher scores indicating higher levels of anxiety or depression symptoms.

  3. Change in post-traumatic stress measured by the PTSD Checklist for DSM-5 (PCL-5) [ Time Frame: Baseline, 30 days, 60 days ]
    The PCL-5 is a 20-item self-report measure corresponding to the Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5) criteria for PTSD. A total symptom severity score (0-80) can be obtained by summing all of the items with higher scores indicating higher severity of PTSD symptoms.

  4. Change in health-related quality of life measured by Medical Outcomes Study 12-item Short-Form General Health Survey (SF- 12) [ Time Frame: Baseline, 60 days ]
    The SF-12 is a 12-item self-report scale measuring health-related quality of life. Each item on the scale is scored using a Likert-type scale with raw scores transformed to a 0 (worst) to 100 (best) scale. The scale provides a summary score of 0 to 100 for physical and mental quality of life with higher scores representing a more positive quality of life.

  5. Change in Mental Health Self-Efficacy Scale (MHSES) score [ Time Frame: Baseline, 30 days, 60 days ]
    The MHSES is a 6-item scale measuring mental health self-efficacy. Each item is measured on a 10-point Likert scale ranging from 1 (not at all confident) to 10 (totally confident). Items are summed for a total score ranging from 6-60 with higher scores indicating higher levels of mental health self-efficacy.


Secondary Outcome Measures :
  1. App usage [ Time Frame: From enrollment to study completion (60 days) ]
    Total number of logins and total number of minutes spent using app



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years of age or older
  • self-identifies as the family decision-maker of the critically ill patient
  • reads and speaks English
  • owns a smartphone with iOS or Android operating system
  • critically ill family member has been in the ICU greater than three days
  • critically ill family member is mechanically ventilated and lacks cognitive capacity
  • critically ill family member is not expected to be transferred out of the ICU within the next 48 hours
  • critically ill family member is 18 years of age or older.

Exclusion Criteria:

  • Employee of Summa Health System

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): NCT04316767


Contacts
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Contact: Amy B Petrinec, PhD 330-715-2987 apetrine@kent.edu
Contact: Richard George, MD 330-375-3000 georger@summahealth.org

Locations
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United States, Ohio
Summa Health System Recruiting
Akron, Ohio, United States, 44304
Contact: Amy B Petrinec, PhD    330-715-2987    apetrine@kent.edu   
Contact: Richard George, MD    330-375-3000    georger@summahealth.org   
Sponsors and Collaborators
Kent State University
Summa Health System
Investigators
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Principal Investigator: Amy B Petrinec, PhD Kent State University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Amy Petrinec, Assistant Professor, Kent State University
ClinicalTrials.gov Identifier: NCT04316767    
Other Study ID Numbers: AACN 416051
First Posted: March 20, 2020    Key Record Dates
Last Update Posted: September 2, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to make individual participant data (IPD) available.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Amy Petrinec, Kent State University:
PICS-F
mobile health app
health-related quality of life
mental health self-efficacy
cognitive behavioral therapy
ICU family
Additional relevant MeSH terms:
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Syndrome
Disease
Pathologic Processes