Ignite Creation Date:
2024-05-06 @ 2:25 PM
Last Modification Date:
2024-10-26 @ 1:31 PM
Study NCT ID:
NCT04316767
Status:
UNKNOWN
Last Update Posted:
2020-09-02
First Post:
2020-03-17
Brief Title:
Self-care App for Family Members of ICU Patients
Sponsor:
Kent State University
Organization:
Kent State University
Study Overview
Official Title:
Smartphone Delivery of Cognitive Behavioral Therapy for Post-intensive Care Syndrome-Family A Pilot Study
Status:
UNKNOWN
Status Verified Date:
2020-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
Family members of critically ill patients suffer symptoms of post-intensive care syndrome-family PICS-F including anxiety depression and post-traumatic stress disorder with a diminished quality of life These symptoms persist long after the episode of critical illness and can linger for years Cognitive behavioral therapy has become the primary non-pharmacological treatment of an increasing list of psychological symptoms and disorders including anxiety depression and post-traumatic stress For mild-to-moderate symptoms mobile technology delivery of cognitive behavioral therapy without input from a clinician has been found to be feasible and well-accepted with efficacy that rivals face-to-face therapy
The purpose of this pilot study is to examine the efficacy of smartphone delivery of cognitive behavioral therapy via a mobile health app intervention on the severity and prevalence of PICS-F symptoms in family members of critically ill patients The study will include family members of critically ill patients admitted to two 26-bed ICUs at the Akron campus of Summa Health System A prospective repeated measures longitudinal design with randomization to two groups control intervention will be employed Primary outcome measures will include symptoms of PICS-F anxiety depression post-traumatic stress health-related quality of life and mental health self-efficacy measured at enrollment 30 days after enrollment and 60 days after enrollment App usage over the course of the study number of logins total time spent with app will be obtained at the final time point of the study 60 days after enrollment A sample size of 60 family members is planned for this pilot study 30 intervention 30 control The sample size was determined according to the recommendations of Whitehead et alestimating an a priori small effect size and an attrition rate of 30 derived from previous studies
The aims of the study are
Aim 1 Determine the prevalence and severity of PICS-F symptoms anxiety depression post-traumatic stress health-related quality of life HRQOL and mental health self-efficacy MHSE in family decision makers of critically ill patients and their change over time enrollment 30 days 60 days
Aim 2 Determine differences in PICS-F symptom severity HRQOL and MHSE in family decision makers of critically ill patients receiving a mobile health app MHapp intervention compared to family members receiving standard care and support
Aim 3 Determine the relationship between the dose of the MHapp total time spent with the app total log-ins over the course of the study 60 days and changes in PICS-F symptom severity anxiety depression post-traumatic stress HRQOL and MHSE
Data Analysis and Statistical Plan Data will be analyzed using Statistics Package for the Social Sciences SPSS Version 25 software Descriptive statistics will be used to assess frequencies and variability of the data coding inaccuracies outliers and missing data The statistical plan for each specific aim is as follows
Aim 1 The investigators will report study variables with descriptive statistics Change over time will be examined with repeated measures ANOVA
Aim 2 Differences between intervention and control groups will be assessed with students t-test Differences between groups in regard to severity of PICS-F symptoms will be used to calculate effect size for the intervention
Aim 3 Relationship between total MHapp dose and longitudinal change in study variables will be examined with Pearsons correlation
Human Subjects and Ethical Issues The research presents no more than minimal psychological risk or harm largely from the possibility that answering the questions on the anxiety depression and stress instruments may be distressing for participants Psychological risk will be minimized by emphasizing that study participants can stop participating in the study at any time and are not obligated to answer any question that they find distressing Family members who endorse clinically significant symptoms will be referred to their primary care physician Family members of patients who die during the study will be referred to local bereavement support groups
There is a low risk of privacy or confidentiality loss Risk will be minimized by the following measures a the only record linking the participant and the research data is the consent document b consent documents will be kept in a locked cabinet in the locked office of the PI c data will be entered and stored by the RA on REDCap a secure HIPAA-compliant web-based platform d all data files obtained for analysis will be stored on a password-protected laptop computer stored in a locked room and e The PI co-investigators and research assistant RA are the only individuals with access to the data files
The purpose of this pilot study is to examine the efficacy of smartphone delivery of cognitive behavioral therapy via a mobile health app intervention on the severity and prevalence of PICS-F symptoms in family members of critically ill patients The study will include family members of critically ill patients admitted to two 26-bed ICUs at the Akron campus of Summa Health System A prospective repeated measures longitudinal design with randomization to two groups control intervention will be employed Primary outcome measures will include symptoms of PICS-F anxiety depression post-traumatic stress health-related quality of life and mental health self-efficacy measured at enrollment 30 days after enrollment and 60 days after enrollment App usage over the course of the study number of logins total time spent with app will be obtained at the final time point of the study 60 days after enrollment A sample size of 60 family members is planned for this pilot study 30 intervention 30 control The sample size was determined according to the recommendations of Whitehead et alestimating an a priori small effect size and an attrition rate of 30 derived from previous studies
The aims of the study are
Aim 1 Determine the prevalence and severity of PICS-F symptoms anxiety depression post-traumatic stress health-related quality of life HRQOL and mental health self-efficacy MHSE in family decision makers of critically ill patients and their change over time enrollment 30 days 60 days
Aim 2 Determine differences in PICS-F symptom severity HRQOL and MHSE in family decision makers of critically ill patients receiving a mobile health app MHapp intervention compared to family members receiving standard care and support
Aim 3 Determine the relationship between the dose of the MHapp total time spent with the app total log-ins over the course of the study 60 days and changes in PICS-F symptom severity anxiety depression post-traumatic stress HRQOL and MHSE
Data Analysis and Statistical Plan Data will be analyzed using Statistics Package for the Social Sciences SPSS Version 25 software Descriptive statistics will be used to assess frequencies and variability of the data coding inaccuracies outliers and missing data The statistical plan for each specific aim is as follows
Aim 1 The investigators will report study variables with descriptive statistics Change over time will be examined with repeated measures ANOVA
Aim 2 Differences between intervention and control groups will be assessed with students t-test Differences between groups in regard to severity of PICS-F symptoms will be used to calculate effect size for the intervention
Aim 3 Relationship between total MHapp dose and longitudinal change in study variables will be examined with Pearsons correlation
Human Subjects and Ethical Issues The research presents no more than minimal psychological risk or harm largely from the possibility that answering the questions on the anxiety depression and stress instruments may be distressing for participants Psychological risk will be minimized by emphasizing that study participants can stop participating in the study at any time and are not obligated to answer any question that they find distressing Family members who endorse clinically significant symptoms will be referred to their primary care physician Family members of patients who die during the study will be referred to local bereavement support groups
There is a low risk of privacy or confidentiality loss Risk will be minimized by the following measures a the only record linking the participant and the research data is the consent document b consent documents will be kept in a locked cabinet in the locked office of the PI c data will be entered and stored by the RA on REDCap a secure HIPAA-compliant web-based platform d all data files obtained for analysis will be stored on a password-protected laptop computer stored in a locked room and e The PI co-investigators and research assistant RA are the only individuals with access to the data files
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None