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Parental Experience in the Single Ventricle Interstage Utilizing a mHealth Innovation: A Comparative Case Study

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ClinicalTrials.gov Identifier: NCT03231020
Recruitment Status : Completed
First Posted : July 27, 2017
Last Update Posted : July 31, 2020
Sponsor:
Collaborator:
American Nurse Credentialing Center
Information provided by (Responsible Party):
Lori Erickson, Children's Mercy Hospital Kansas City

Brief Summary:
The purpose of this study is to provide a rich description of the parental perspectives of utilizing a mHealth application for data transfer during the single ventricle interstage monitoring period. A gap in the body of knowledge of single ventricle cardiac disease interstage will be explored with these research questions: 1) How do parents of children (< 5 years of age) with single ventricle disease describe their experiences using a mHealth application during the interstage period (first 6-12 months of child's life)? And 2) How do these experiences influence their decision making for use of the mHealth application?

Condition or disease Intervention/treatment
mHealth Adherence, Patient Other: Interview

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Study Type : Observational
Actual Enrollment : 11 participants
Observational Model: Family-Based
Time Perspective: Prospective
Official Title: Parental Experience in the Single Ventricle Interstage Utilizing a mHealth Innovation: A Comparative Case Study
Actual Study Start Date : September 13, 2019
Actual Primary Completion Date : April 26, 2020
Actual Study Completion Date : May 30, 2020

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Group/Cohort Intervention/treatment
Adherent Group
Parent(s) that submitted a high rate of data transfer (top 25th percentile) with rate of data days of mHealth technology for data transfer
Other: Interview
The proposed research study uses a comparative case study methodology, utilizing multiple sources of data to deeply examine 8-10 "cases," each of which is defined as parent(s) of a child (< 5 years of age) with single ventricle disease who used the mHealth application. One group of cases (4-5) will have used the mHealth application less than recommended (non-adherent to the home monitoring recommendations) or declined to use the application and returned it before the end of the interstage period. The other group of comparison cases (4-5 cases) will have used the application as recommended by the clinical team (adherent) and continued doing so through the interstage period.

Non-Adherent Group
Parent(s) that chose to return mHealth technology before the end of the interstage period and/or low rate of data transfer (bottom 25th percentile) with rate of data days
Other: Interview
The proposed research study uses a comparative case study methodology, utilizing multiple sources of data to deeply examine 8-10 "cases," each of which is defined as parent(s) of a child (< 5 years of age) with single ventricle disease who used the mHealth application. One group of cases (4-5) will have used the mHealth application less than recommended (non-adherent to the home monitoring recommendations) or declined to use the application and returned it before the end of the interstage period. The other group of comparison cases (4-5 cases) will have used the application as recommended by the clinical team (adherent) and continued doing so through the interstage period.




Primary Outcome Measures :
  1. Adherence to technology [ Time Frame: 6 months ]
    parental perspective on interstage period will influence the number of Data days during the interstage period


Secondary Outcome Measures :
  1. Non-adherence to mHealth technology [ Time Frame: 6 months ]
    Parental perception of non-adherence of mHealth (CHAMP) and communication to the clinical team will match the actual non-adherence patterns of the mHealth innovation

  2. Parental Stress [ Time Frame: 6 months ]
    Parents of infants with single ventricle will report the interstage report as a stressful time



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Purposeful sampling will be used for recruiting among the first 80 infants from that used Cardiac High Acuity Monitoring Program (CHAMP) mHealth. All single and dual parent case sets will be recruited from a single tertiary center's pediatric cardiology department that used a mHealth application during the interstage period with the single ventricle team clinic known as CHAMP. Thus a case will be defined as the parent(s) of a single ventricle child who utilized CHAMP to monitor their baby at home during interstage with preliminary screening from the CHAMP Webportal through Children's Mercy Kansas City.
Criteria

Inclusion Criteria:

  1. Adult over 18 years of age parent(s) of children with single ventricle cardiac disease
  2. Parent(s) of children were discharge home in the interstage period from December 2013 to May 2017 that have completed the interstage period with Stage II Glenn cardiac surgery as of June 8th, 2017.
  3. Parents(s) of children who were followed in the CHAMP clinic at Children's Mercy.
  4. Parent(s) of CHAMP children who had the CHAMP mHealth application (CHAMP App) available for transfer of home monitoring data during the interstage

Exclusion Criteria:

  1. Non-English speaking parent(s)
  2. Parent(s) of children who were not discharged interstage

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): NCT03231020


Locations
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United States, Missouri
Children's Mercy Kansas City
Kansas City, Missouri, United States, 64108
Sponsors and Collaborators
Children's Mercy Hospital Kansas City
American Nurse Credentialing Center
Investigators
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Principal Investigator: Lori Erickson, MSN Children's Mercy Kansas City
Publications:
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Responsible Party: Lori Erickson, CHAMP Clinical Program Manager, MSN, CPNP-PC, Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier: NCT03231020    
Other Study ID Numbers: 17050339
First Posted: July 27, 2017    Key Record Dates
Last Update Posted: July 31, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Lori Erickson, Children's Mercy Hospital Kansas City:
single ventricle
pediatric cardiology
interstage
home monitoring
mHealth