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

NCT03231020 | Completed

• 1 other identifier: 17050339
• Study Type: observational
• Target: 11
• Locations: 1 country
• Sites: 1

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?

Conditions

mHealth; Adherence, Patient

Keywords

single ventricle; pediatric cardiology; interstage; home monitoring; mHealth

Outcome Measures

Primary Outcomes (1)

• Adherence to technology

  parental perspective on interstage period will influence the number of Data days during the interstage period

  6 months

Secondary Outcomes (2)

• Non-adherence to mHealth technology

  6 months

• Parental Stress

  6 months

Study Arms (2)

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

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

Interventions

Interview OTHER

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.

Adherent Group; Non-Adherent Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Adult over 18 years of age parent(s) of children with single ventricle cardiac disease
• 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.
• Parents(s) of children who were followed in the CHAMP clinic at Children's Mercy.
• Parent(s) of CHAMP children who had the CHAMP mHealth application (CHAMP App) available for transfer of home monitoring data during the interstage

You may not qualify if:

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

Sponsors & Collaborators

• Children's Mercy Hospital Kansas City: lead
• American Nurse Credentialing Center: collaborator

Study Sites (1)

Children's Mercy Kansas City

Kansas City, Missouri, 64108, United States

Location

Related Publications (4)

• Shirali G, Erickson L, Apperson J, Goggin K, Williams D, Reid K, Bradley-Ewing A, Tucker D, Bingler M, Spertus J, Rabbitt L, Stroup R. Harnessing Teams and Technology to Improve Outcomes in Infants With Single Ventricle. Circ Cardiovasc Qual Outcomes. 2016 May;9(3):303-11. doi: 10.1161/CIRCOUTCOMES.115.002452. Epub 2016 May 10.

  PMID: 27166202 BACKGROUND

• Yin RK. Enhancing the quality of case studies in health services research. Health Serv Res. 1999 Dec;34(5 Pt 2):1209-24.

  PMID: 10591280 BACKGROUND

• Black AK, Sadanala UK, Mascio CE, Hornung CA, Keller BB. Challenges in implementing a pediatric cardiovascular home telehealth project. Telemed J E Health. 2014 Sep;20(9):858-67. doi: 10.1089/tmj.2013.0343. Epub 2014 Aug 1.

  PMID: 25083905 BACKGROUND

• Rempel GR, Harrison MJ. Safeguarding precarious survival: parenting children who have life-threatening heart disease. Qual Health Res. 2007 Jul;17(6):824-37. doi: 10.1177/1049732307303164.

  PMID: 17582024 BACKGROUND

MeSH Terms

Conditions

Patient Compliance; Univentricular Heart

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Lori Erickson, MSN

  Children's Mercy Kansas City

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: FAMILY BASED
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: CHAMP Clinical Program Manager, MSN, CPNP-PC

Study Record Dates

• First Submitted: July 12, 2017
• First Posted: July 27, 2017
• Study Start: September 13, 2019
• Primary Completion: April 26, 2020
• Study Completion: May 30, 2020
• Last Updated: July 31, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)