Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03231020
Other study ID # 17050339
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 13, 2019
Est. completion date May 30, 2020

Study information

Verified date July 2020
Source Children's Mercy Hospital Kansas City
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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?


Description:

Background Nearly 2,000 infants with single ventricle cardiac disease are born each year in the United States, and have near certain mortality without surgical intervention. The heart with this congenital disease can never be converted to a four-chambered heart but rather, a palliative three-staged surgical strategy has been designed to maintain both circulation to the body and lungs without a pump. After an initial neonatal surgery, most infants are discharged home and return for a second surgery around six months of life. The time occurring between surgeries is known as the interstage period. This interstage period is very high risk and high demand time for parents, and there is a mortality rate during the interstage ranging from 2-20%, often from unknown reasons.

Hypoplastic left heart syndrome (HLHS) is a specific type of single ventricle disease that is one of the most complex forms of congenital heart disease. Publications have focused on improving the care of infants with HLHS using a Quality Improvement Model with the National Pediatric Cardiology Quality Improvement Collaborative (NPCQIC) through reduced variation, best practices, and transparency. The concept of interstage home monitoring to reduce mortality also was primarily focused on infants with only HLHS until recently when the focus was made onto comprehensive care from birth to 1 year of age. Hemodynamic data such as oxygen saturation, heart rate, intake, and overall status from a parental perspective were used to promote communication and attempts of early recognition of deterioration in this high-risk population. A strong set of qualitative studies have come from Rempel et al. in Canada on a cross-section of mainly white married parents of infants with HLHS and their parenting experience. Parenting under Pressure and the Facets of parenting a child with HLHS were studies which used the grounded theory approach and provided substantial additions to our knowledge of the interstage HLHS parenting experience. The basis of much of the care for all types of single ventricle cardiac disease at home is found from the care of HLHS and applied to infants with all types of single ventricle anatomy.

Most hospitals with pediatric cardiac surgery programs have interstage home monitoring programs for high risk infants with single ventricle heart disease to provide care and support for infants with all types of single ventricle cardiac disease. Education for caregivers of infants with single ventricle disease include guidelines to call health care providers (HCPs) in cases of hemodynamic interstage concerns, and symptom management questions, based on home monitoring of oxygen saturation and weight gain. There are variations in the staffing structure between pediatric hospitals but the programs often include care coordination and education by a nurse or advanced practice nurse communicating with parents in a reactive model waiting for data to be reported.

mHealth is defined through the National Institutes of Health (NIH) as the use of mobile and wireless devices to improve health outcomes, service, and research. The use of applications is widespread in adult care with estimated 40,000 health-care applications available. Some studies in pediatric medical homes have shown association of mHealth with adherence and self-monitoring to improved outcomes. mHealth innovations like the Cardiac High Acuity Monitoring Program (CHAMP) and other applications work most effectively when caregivers and interstage programs work together to improve care and are a focus of future research from the National Institute of Nursing Research. Much of the recent interstage literature focuses on mortality and weight measures with little focus on expanding types of outcomes to the parental and interstage teams' perspectives and phenomena like infant development.

Recent developments in technology can provide a proactive means for data transfer for home symptom monitoring so the interstage nursing team can review trends and provide proactive monitoring for infants in the interstage. Since 2012, two pilot studies have been published illustrating varying types of mHealth for the interstage with outcomes of improved somatic growth and an improved system of interstage data review but did not show significant mortality improvements. An innovative mHealth technology, CHAMP, was begun in 2014 for interstage home monitoring symptom management and found improved interstage mortality outcomes compared with historical controls. Research gaps remain in the role of adherence in this population to the mHealth technology and the parental experience of utilizing these innovative methods for communication with the clinical team.

Rationale 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 for infants with congenital heart disease. The use of the case study design in healthcare has been encouraged by Robert Yin because it adapts to the complexity of interactions in a system that may be rapidly changing. Yin's qualitative case research "design propositions", presented below for this study, are applied to the literature and the PI's professional experience to focus the scope of the study and improve feasibility of completion of this qualitative case study approach research study. Propositions in this type of qualitative design are similar to hypothesis in quantitative designs to help formulate themes emerging from the data. The use of propositions may help with contributions for the body of knowledge after generalizing case study analysis, especially in cases of critical or extreme cases. Comparative analysis of the theoretical target (non-adherent parents) and rival cases (adherent parents) within the case study are improved with study propositions to guide the organization of data.

Study Propositions:

1. The parental perspectives of the interstage period will influence the use of a home monitoring mHealth technology

2. Parental perception of non-adherence of CHAMP and communication to the clinical team will match the actual non-adherence patterns of the mHealth innovation

3. The use of Cardiac High Acuity Monitoring Program (CHAMP) application from the parental perspective will benefit future improvements in this technology

4. Parents of infants with single ventricle will report the interstage report as a stressful time

Research Design

Methods. 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.

Yin defines various types of cases, including, explanatory or causal case studies, descriptive case studies, and exploratory case studies. The cases in this study are exploratory in that they focus on "what" can be learned from these cases of using a novel mHealth innovation and the CHAMP care team as a unit. Across the U.S., nearly 2,000 infants are born with single ventricle cardiac disease each year but the actual experience at home is difficult to comprehend. The research design is a multiple case study design with embedded units of non-adherent and adherent cases of parental use of CHAMP within the larger case group through the CHAMP Clinic at Children's Mercy Kansas City.

Data sources will include semi-structured interviews with parents that include observations of simulated home monitoring equipment and processes that had been previously used including location, time of day, and frequency.


Recruitment information / eligibility

Status Completed
Enrollment 11
Est. completion date May 30, 2020
Est. primary completion date April 26, 2020
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Children's Mercy Kansas City Kansas City Missouri

Sponsors (2)

Lead Sponsor Collaborator
Children's Mercy Hospital Kansas City American Nurse Credentialing Center

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

Rempel GR, Harrison MJ. Safeguarding precarious survival: parenting children who have life-threatening heart disease. Qual Health Res. 2007 Jul;17(6):824-37. — View Citation

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. — View Citation

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

Outcome

Type Measure Description Time frame Safety issue
Primary Adherence to technology parental perspective on interstage period will influence the number of Data days during the interstage period 6 months
Secondary Non-adherence to mHealth technology 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 6 months
Secondary Parental Stress Parents of infants with single ventricle will report the interstage report as a stressful time 6 months
See also
  Status Clinical Trial Phase
Completed NCT04817176 - MI-CBT Adherence Program for Lifestyle Interventions in Older Adults Early Phase 1
Completed NCT03044145 - The Cultural Formulation Interview-Engagement Aid N/A
Completed NCT03402802 - Steroid Eyedrop Adherence After Trabeculectomy
Recruiting NCT03625674 - Impact of Stigma on Compliance to Medication in Functional Dyspepsia N/A
Active, not recruiting NCT04424368 - Remote Monitoring System for Patients, Who Had Myocardial Infarction N/A
Completed NCT04169646 - Prevention and Intervention of Neck Pain in Swiss Office-Workers N/A
Recruiting NCT03721445 - Could HRV be a Valuable Predictor for CPAP Adherence?
Recruiting NCT05832008 - Increasing Adherence to Lung Cancer Screening N/A
Completed NCT03484637 - Response Evolution Chart
Completed NCT03710213 - Automated Navigation to Improve Outpatient Colonoscopy Adherence N/A
Active, not recruiting NCT04166422 - Virtual Reality and Video Games in Cardiac Rehabilitation Programs N/A
Terminated NCT03109743 - Group Clinical Visit Adherence Intervention for HIV+ Women of Color N/A
Completed NCT03883282 - Influence of Participation in Randomized Controlled Trials on adheRence to Medicines' Intake and regUlar viSits to the docTor
Recruiting NCT05709145 - Written Recommendation to Improve Adherence in Poor Bowel Preparation N/A
Not yet recruiting NCT06195839 - Building Engagement Using Financial Incentives Trial - Hypertension N/A
Recruiting NCT05159089 - Physical Activity Drop-out Ratio in Patients Living With Type 2 Diabetes N/A
Completed NCT06068699 - Postcards to Improve Remote Monitoring Adherence Among Veterans N/A
Completed NCT03340428 - Post-release Retention in HIV Care for Ex-inmates in South Africa N/A
Recruiting NCT05613010 - Leveraging Technology to Improve Medication Adherence in Youth With Kidney or Liver Transplant N/A
Completed NCT03867903 - BabySparks Developmental Application Pilot Study