NCT00971139

Brief Summary

This interdisciplinary, international collaboration study, including the the Norwegian Health Economy Administration (HELFO) will evaluate the effectiveness and real-world implementation of an online patient-provider communication (OPPC) service into rout ine practice. In Phase I we will identify patients and care providers requirements and organizational contexts, and use participatory design methods to adapt the OPPC service to users needs and the context of clinical practice. In Phase II we will offer study participants access to the OPPC service to understand implementation issues. In addition, we will conduct a pilot randomized clinical trial (usual care; OPPC) with 40 patients in each group that will be followed over 6 months.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
199

participants targeted

Target at P50-P75 for not_applicable cancer

Timeline
Completed

Started Nov 2009

Longer than P75 for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 1, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 3, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2009

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

November 3, 2015

Status Verified

November 1, 2015

Enrollment Period

3.5 years

First QC Date

September 1, 2009

Last Update Submit

November 2, 2015

Conditions

Keywords

Online patient-provider communicationOrganizational changeSymptom management

Outcome Measures

Primary Outcomes (1)

  • Impacts of the OPPC service on organizational processes/organizational change such as care processes

    End of study at 6 (8) months after last included patient

Secondary Outcomes (2)

  • Participation rate and OPPC use, perceived usefulness and ease of use

    End of study at 6 (8) months after last included patient

  • Characteristics of high/low volume users, patient-caregiver communication and use patterns

    End of study at 6 (8) months after last included patient

Study Arms (2)

Access to an OPPC service

EXPERIMENTAL

Access to an Internet-based messaging system where patients can ask questions and receive advice and support from care providers at the hospital and social counsellors

Behavioral: Access to an OPPC service

Control group

NO INTERVENTION

Patients receiving usual care

Interventions

Access to an Internet-based messaging system where patients can ask questions and receive advice and support from care providers at the hospital and social counsellors

Access to an OPPC service

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age.
  • Able to read/speak Norwegian and have Internet with secure access (BankID) at home.

You may not qualify if:

  • Excluded are patients who have brain metastasis and patients with cerebral affection caused by the disease (e.g., encephalopathy) as this may affect their abilities to reliably report their symptoms.
  • Excluded are also patients who receive a liver transplant indicated by cancer coli, as they participate in another study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo University Hospital - Rikshospitalet

Oslo, 0027, Norway

Location

Related Publications (5)

  • Ruland CM, Borosund E, Varsi C. User requirements for a practice-integrated nurse-administered online communication service for cancer patients. Stud Health Technol Inform. 2009;146:221-5.

    PMID: 19592838BACKGROUND
  • Varsi C, Gammon D, Wibe T, Ruland CM. Patients' reported reasons for non-use of an internet-based patient-provider communication service: qualitative interview study. J Med Internet Res. 2013 Nov 11;15(11):e246. doi: 10.2196/jmir.2683.

  • Wibe T, Helleso R, Varsi C, Ruland C, Ekstedt M. How does an online patient-nurse communication service meet the information needs of men with recently diagnosed testicular cancer? ISRN Nurs. 2012;2012:260975. doi: 10.5402/2012/260975. Epub 2012 Dec 4.

  • Wibe T, Ekstedt M, Helleso R, Varsi C, Ruland C. "You are not at all bothersome" - nurses' online communication with testicular cancer patients. NI 2012 (2012). 2012 Jun 23;2012:453. eCollection 2012.

  • Varsi C, Ekstedt M, Gammon D, Ruland CM. Using the Consolidated Framework for Implementation Research to Identify Barriers and Facilitators for the Implementation of an Internet-Based Patient-Provider Communication Service in Five Settings: A Qualitative Study. J Med Internet Res. 2015 Nov 18;17(11):e262. doi: 10.2196/jmir.5091.

MeSH Terms

Conditions

NeoplasmsDiabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Cornelia M Ruland, PhD

    Oslo University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 1, 2009

First Posted

September 3, 2009

Study Start

November 1, 2009

Primary Completion

May 1, 2013

Study Completion

December 1, 2013

Last Updated

November 3, 2015

Record last verified: 2015-11

Locations