Nurse-assisted Intervention "eHealth@ Hospital -2-home"

Not Applicable

Active, not recruiting

• Conditions: Non Communicable Diseases; Colon Rectal Cancer; Heart Failure

• Registration Number: NCT05750953
• Lead Sponsor: University of Stavanger

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 remote patient monitoring (RPM) intervention "eHealth@ Hospital-2-Home". The RPM 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.

Study Timeline

• Study First Submitted: 2022-11-02
• Study First Submitted QC: 2023-02-27
• Study First Posted: 2023-03-02
• Study Start: 2023-05-05
• Status Verified: 2024-12
• Last Update Submitted: 2025-08-12
• Last Update Posted: 2025-08-17
• Primary Completion: 2025-12-15
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 204

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in patient confidence in self-management activities.	Baseline (at discharge), post-1 (42 days following baseline, at the end of the intervention), and post-2 (6 months after baseline)	Change in the patient's confidence in self-management of heart failure or colon-rectal cancer disease between baseline and post-1 and 2 will be measured by the 6 items questionnaire Self-Efficacy for Managing Chronic Disease". Values: 1-10. A higher score mean a better outcome.

Secondary Outcome Measures

Name	Time	Method
Change in patient experience with treatment and self-management.	Baseline (at discharge), post-1(42 days following baseline, at the end of the intervention) , and post-2 (6 months after baseline)	Change in the patient's experience with treatment and self-management of heart failure and colon-rectal cancer between baseline and post-1 and 2 will be measured by the questionnaire "Patient Experience with Treatment and Self-management" with four dimensions of Medical information (Values:1-6); Monitoring health (Values: 1-6); Medications (Values 1- 5); Medical appointments (Values: 1-5). Higher scores means a worse outcome.
Change in patient experience of health condition and how it affects daily life.	Baseline (at discharge), post-1 (42 days following baseline, at the end of the intervention), and post-2 (6 months after baseline)	Change in the patient's Health Related Quality of Life between baseline and post 1 and 2 will be measured with the European Quality of life 5 Dimensions -5 Levels questionnaire. Values: 1-5, were higher scores mean worse outcome, and on a visual analog scale from 0-100, were higher scores mean better outcome.
Change in patient experience of constructive support from healthcare personnel	Baseline (at discharge), post-1 (42 days following baseline, at the end of the intervention), and post-2 (6 months after baseline)	Change in perceived support between baseline and post-1 and 2 will be measured using 12 items on constructive support. Values: 1-5-point. Higher score mean worse outcome.
Change in patient experience of shared decision-making.	Baseline (at discharge), post-1 (42 days following baseline, at the end of the intervention), and post-2 (6 months after baseline)	Change in the patient's experience of shared decision-making between baseline and post-1 and 2 will be measured using the 3 items questionnaire "CollaboRATE" Value: 0-10. Higher score mean better outcome.
Change in health care utilization	Baseline (at discharge), post-1 (42 days following baseline, at the end of the intervention), and post-2 (6 months after baseline)	Change in health care utilization between baseline and post-1 and 2 will be measured using patients' self-reports of number of visits to the primary healthcare service (i.e., General Practitioner, municipal emergency department) and/or the specialist healthcare service (i.e., outpatient clinic). Fewer visits mean better outcome.
Days alive and out of hospital	Post-2 (6 months after baseline)	Days alive and out of hospital (Cohn 2009) will be collected from hospital records and subtracting the number of days spent away from home due to hospitalisation from the date of discharge up to date of death/six months (Post-2), i.e. possible range will be 0-180 days.
Time to first readmission or death	Time of first readmission within six months or death	Time of first readmission within six months will be collected from hospital records, as will date of death (dod) for those who died within six months from the date of discharge from the primary hospitalisation. The first of these dates will define the endpoint for this outcome.

Trial Locations

Locations (1)

Anne Marie Lunde Husebø; 🇳🇴 Stavanger, Rogaland, Norway