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Trial Title:
Nurse-assisted Intervention "eHealth@ Hospital -2-home"
NCT ID:
NCT05750953
Condition:
Non Communicable Diseases
Heart Failure
Colon Rectal Cancer
Conditions: Official terms:
Noncommunicable Diseases
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
A randomized controlled trial with intervention and control group
Primary purpose:
Health Services Research
Masking:
Single (Investigator)
Masking description:
Randomization will be blinded for the researchers performing the data analysis.
Intervention:
Intervention type:
Behavioral
Intervention name:
eHealth@Hospital-2-Home
Description:
At hospital discharge, the intervention group will receive a wireless, portable personal
computer system (i.e., IPAD) that includes the eHealth application MyDignio supplied by a
certified m-Health company. MyDignio app is linked to monitoring devices by Bluetooth for
each patient to daily and weekly measure clinical measures such as blood pressure, pulse,
temperature, and weight, and self-reported symptoms and well-being, and daily report
clinical measurements to the Nurse Navigators employed in the two hospitals. The patients
will receive training from the nurses on how to log on and use the MyDignio app and the
monitoring devices. Telephone contact details including information about how to access
technical support will be provided to each study participant shortly following discharge.
Arm group label:
eHealth@H-2-H
Other name:
nurse-assisted eHealth intervention on self-management among patients with Non-Communicable Disease
Summary:
A randomized controlled trial with non-communicable disease patients from two medical
hospitals in Norway will be recruited prior to hospital discharge. The intervention group
will participate in a 42-day nurse-assisted eHealth intervention "eHealth@
Hospital-2-Home". The intervention includes monitoring the patient's vital signs,
self-reports of symptoms, health and well-being, communication between the patients and a
Nurse Navigator in the hospital, and access to information about illness and health
resources.
Detailed description:
Heart failure (HF) and colon-rectal cancer (CRC) are two non-communicable diseases (NCDs)
prone to a high rate of hospital admissions and re-admissions, and complex health care
needs. For many patients with HF and CRC, self-management following hospitalization can
be a challenge, and they may leave the hospital unprepared for self-managing their
disease at home. The randomized controlled trial with NCD patients from two medical
hospitals in Norway. Patients will be recruited before hospital discharge. The
intervention group will participate in a 42-day nurse-assisted intervention ""eHealth@
Hospital-2-Home"". The intervention includes monitoring of patients' vital signs,
self-reports of symptoms, health and well-being, communication between the patients and a
Nurse Navigator in the hospital, and access to information about illness and health
resources. The control group will receive care as usual. Data collection will take place
before the intervention (baseline), at the end of the intervention (post-1), and 6 months
after baseline (post-2). Data will be according to intention to treat principles.
Qualitative data will be analyzed using thematic analysis.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- All participants: symptomatic HF or surgically treated for either colon or rectal
cancer (Colon-Rectal Cancer Duke's class 1-3, curative), able to speak and write
Norwegian
Exclusion Criteria:
- Heart failure population: patient is on a waiting list for a heart transplant,
requires a Left Assist Ventricular Device (LVAD), and has a life expectancy <6
months
- Colon-rectal cancer population: metastatic cancer, Surgical Complication Score > 3,
and acute medical crisis.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Anne Marie Lunde Husebø
Address:
City:
Stavanger
Zip:
4036
Country:
Norway
Status:
Recruiting
Contact:
Last name:
Svein Scheie, MD, PhD
Email:
svein.skeie@sus.no
Contact backup:
Last name:
Marianne Storm, PhD
Phone:
004748133750
Phone ext:
Storm
Email:
marianne.storm@uis.no
Investigator:
Last name:
Marianne Storm, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Ingvild M Morken, PhD
Email:
Principal Investigator
Investigator:
Last name:
Anne Marie L Husebø, PhD
Email:
Principal Investigator
Start date:
May 5, 2023
Completion date:
December 31, 2024
Lead sponsor:
Agency:
University of Stavanger
Agency class:
Other
Collaborator:
Agency:
Helse Stavanger HF
Agency class:
Other
Collaborator:
Agency:
St. Olavs Hospital
Agency class:
Other
Source:
University of Stavanger
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05750953
