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Supporting Patient Provider Communication in Paediatric Care (SiSom)

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: NCT01280227
Recruitment Status : Completed
First Posted : January 20, 2011
Last Update Posted : April 6, 2017
Sponsor:
Collaborator:
The Research Council of Norway
Information provided by (Responsible Party):
Cornelia Ruland, Oslo University Hospital

Tracking Information
First Submitted Date  ICMJE September 1, 2009
First Posted Date  ICMJE January 20, 2011
Last Update Posted Date April 6, 2017
Study Start Date  ICMJE January 2005
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 19, 2011)
Patient-provider communication [ Time Frame: Single measure, video recording of medical consultation lasting approximately one hour ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 19, 2011)
  • Patient-provider communication [ Time Frame: Single measure, video recording of medical consultation lasting approximately one hour ]
  • Time requirements, ease of use [ Time Frame: Single measure, after collection of all patient data ]
  • Congruence between children's reported symptoms and problems and those addressed by their clinicians as evidenced in documented patient care. [ Time Frame: Single measure, ten minutes post intervention ]
  • State anxiety [ Time Frame: 10 minutes pre and 10 minutes post intervention ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Supporting Patient Provider Communication in Paediatric Care
Official Title  ICMJE Supporting Patient Provider Communication for Children With Cancer and Congenital Heart Disease
Brief Summary

Children with Cancer or congenital heart disease (CHD) experience complex, physical, psychosocial and behavioural symptoms and problems due to the illness, treatment, and medical procedures. To help children cope with their problems and prevent psychological distress, the investigators developed SiSom, a support system to help children with cancer or CHD report their symptoms and problems in an age-adjusted manner on a touch-pad, portable computer.

This quasi-experimental study with 202 children age 7-12 with CHD or cancer will test the following hypotheses: When children use SiSom to report their symptoms and problems, and this information is provided to their clinicians in their outpatient consultations:

  • Children and parents will experience less anxiety.
  • Children and parents will be more satisfied with the outpatient visit.
  • There will be greater congruence between children's reported symptoms and problems and those addressed by their clinicians as evidenced in documented patient care.

To better understand the mechanisms by which these effects may occur, the investigators will also explore:

  • Differences between control and experimental groups in patient-provider communication in terms of instrumental and affective behaviour, participation, initiative and person addressed;
  • The relationships among outcomes of patient-provider communication, congruence between patients' reported symptoms and those addressed by their clinicians and children's and parents' anxiety and satisfaction; and how these relationships differ between treatment and control conditions.

Finally, the investigators will investigate time requirements, ease of use and usefulness of SiSom by children and clinicians.

For analyses the investigators will use inferential statistics and qualitative analyses of the video-taped consultation sessions. This study will contribute to improving patient-centred care for a particularly vulnerable population, and to a better understanding of the triadic communication and interactions among child-parent and clinician.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Cancer
  • Congenital Heart Disease
Intervention  ICMJE Behavioral: SiSom
SiSom is a symptom assessment tool designed to help the child report disease specific problems.The child also report the severity of their problems. After using the tool a report is printed and given to the clinician.
Other Name: Symptom assessment tool
Study Arms  ICMJE
  • Experimental: 1
    Patients uses the symptom assessment tool SiSom. A summary of their reported symptoms are printed out and given to the pediatrician and nurse before the consultation. The consultation is videotaped.
    Intervention: Behavioral: SiSom
  • No Intervention: 2
    The control group do not use the symptom assessment tool "SiSom" before the consultation. The control group receives usual care and the consultation is videoptaped.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 19, 2011)
144
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2016
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Between 7 and 12 years.
  • Ethnic norwegian.
  • Undergoing treatment for cancer or diagnosed with a congenital heart disease.

Exclusion Criteria:

  • Receiving or have received radiation the brain as this may affect their abilities to use SiSom and communicate during consultations.
  • Syndromes, mental retardation, developmental disorders, language disorders, or cognitive disorders that affect their ability to report symptoms or communicate during consultations.
  • Other ethnic origin.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 7 Years to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01280227
Other Study ID Numbers  ICMJE S-05288
175389/V50
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Cornelia Ruland, Oslo University Hospital
Study Sponsor  ICMJE Oslo University Hospital
Collaborators  ICMJE The Research Council of Norway
Investigators  ICMJE
Principal Investigator: Cornelia M Ruland, PhD Oslo University Hospital
PRS Account Oslo University Hospital
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP