Clinical trial NCT05750953: Nurse-assisted Intervention "eHealth@ Hospital -2-home"
Official title: Project Title: Nurse Assisted EHealth Service from Hospital to Home: Ameliorating Burden of Treatment Among Patients with Non-Communicable Diseases
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Non Communicable Diseases
Heart Failure
Colon Rectal Cancer
Lead sponsor: University of Stavanger
Sponsor class: OTHER
Collaborators: name: Helse Stavanger HF
name: St. Olavs Hospital
First posted: 2023-03-02
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized controlled trial with intervention and control group
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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.

Primary outcomes:
measure: Change in patient confidence in self-management activities.
timeFrame: Baseline (at discharge), post-1 (42 days following baseline, at the end of the intervention), and post-2 (6 months after baseline)
measure: Change in heart failure self-care behavior
timeFrame: Baseline (at discharge), post-1, (42 days following baseline, at the end of the intervention) and post-2 (6 months after baseline)
Secondary outcomes:
measure: Change in patient experience with treatment and self-management.
timeFrame: Baseline (at discharge), post-1(42 days following baseline, at the end of the intervention) , and post-2 (6 months after baseline)
measure: Change in patient experience of health condition and how it affects daily life.
timeFrame: Baseline (at discharge), post-1 (42 days following baseline, at the end of the intervention), and post-2 (6 months after baseline)
measure: Change in patient experience of constructive support from healthcare personnel
timeFrame: Baseline (at discharge), post-1 (42 days following baseline, at the end of the intervention), and post-2 (6 months after baseline)
measure: Change in patient experience of shared decision-making.
timeFrame: Baseline (at discharge), post-1 (42 days following baseline, at the end of the intervention), and post-2 (6 months after baseline)
measure: Change in health care utilization
timeFrame: Baseline (at discharge), post-1 (42 days following baseline, at the end of the intervention), and post-2 (6 months after baseline)
measure: Days alive and out of hospital
timeFrame: Post-2 (6 months after baseline)
measure: Number of 30 days readmission for heart failure or colon-rectal cancer related incidents
timeFrame: Post-1 (42 days following baseline, at the end of the intervention).
measure: Number of 90 days readmission for heart failure or colon-rectal cancer related incidents
timeFrame: Post-2 (6 months following baseline)
measure: Number of 12 months readmission for heart failure or colon-rectal cancer related incidents
timeFrame: Post-3 (12 months following baseline)
Other outcomes:
measure: Change in medication adherence in heart failure patients
timeFrame: Post-1 (42 days following baseline, at the end of the intervention), and post-2 (6 months after baseline).
measure: Patient satisfaction with using the technology.
timeFrame: Post-1 (42 days following baseline, at the end of the intervention)
Locations:
city: Stavanger
country: Norway
facility: Anne Marie Lunde Husebø
state: Rogaland
Study officials:
affiliation: University of Stavanger
name: Anne Marie Husebø, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Stavanger
name: Ingvild M Morken, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Stavanger
name: Marianne Storm, PhD
role: PRINCIPAL_INVESTIGATOR
References: