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CompletedNCT05750953Ehealth@H2HUpdated Aug 14, 2026

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

An interventional study of eHealth@Hospital-2-Home in Non Communicable Diseases, Heart Failure and Colon Rectal Cancer, sponsored by University of Stavanger. Completed at 1 site in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-14.

Sponsored by University of Stavanger · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
204
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Non Communicable Diseases
  • Heart Failure
  • Colon Rectal Cancer
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
204 participants (actual)

Study arms

  • Experimental
    eHealth@H-2-H

    The intervention group will participate in a 42-day nurse-assisted RPM intervention "eHealth@ Hospital-2-Home". The intervention includes monitoring of vital signs, self-reports of symptoms, health and well-being, access to information about illness and health resources , and communication between the patients and a hospital-based Nurse Navigator.

    Behavioral: eHealth@Hospital-2-Home

  • No intervention
    Care as usual

    The control group will receive care as usual

Interventions

  • BehavioraleHealth@Hospital-2-Home

    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.

    Also known as: nurse-assisted eHealth intervention on self-management among patients with Non-Communicable Disease

05

What researchers measure

Primary outcomes

  1. Change in patient confidence in self-management activities.

    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.

    Time frame: Baseline (at discharge), post-1 (42 days following baseline, at the end of the intervention), and post-2 (6 months after baseline)

Secondary outcomes

  1. Change in patient experience with treatment and self-management.

    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.

    Time frame: Baseline (at discharge), post-1(42 days following baseline, at the end of the intervention) , and post-2 (6 months after baseline)

  2. Change in patient experience of health condition and how it affects daily life.

    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.

    Time frame: Baseline (at discharge), post-1 (42 days following baseline, at the end of the intervention), and post-2 (6 months after baseline)

  3. Change in patient experience of constructive support from healthcare personnel

    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.

    Time frame: Baseline (at discharge), post-1 (42 days following baseline, at the end of the intervention), and post-2 (6 months after baseline)

  4. Change in patient experience of shared decision-making.

    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.

    Time frame: Baseline (at discharge), post-1 (42 days following baseline, at the end of the intervention), and post-2 (6 months after baseline)

  5. Change in health care utilization

    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.

    Time frame: Baseline (at discharge), post-1 (42 days following baseline, at the end of the intervention), and post-2 (6 months after baseline)

  6. Days alive and out of hospital

    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 frame: Post-2 (6 months after baseline)

  7. Time to first readmission 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.

    Time frame: Time of first readmission within six months or death

Other outcomes

  1. Patient satisfaction with using the technology.

    Patient satisfaction with using the technology will be measured by the Post-Study System Usability Questionnaire. Values: 1-7. Higher score mean worse outcome.

    Time frame: Post-1 (42 days following baseline, at the end of the intervention)

06

Study locations

1 site
  • Anne Marie Lunde Husebø
    Stavanger, Rogaland 4036, Norway
07

References and documents

Study documents

  • Statistical analysis plan · Aug 25, 2025
  • Statistical analysis plan · Jun 28, 2026

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No — According to legal and ethical legislation and approvals.

08

Registry details

Key details

Study ID
NCT05750953
Lead sponsor
University of Stavanger
Collaborators
Helse Stavanger HF, St. Olavs Hospital
Responsible party
Sponsor
First posted
Mar 2, 2023
Start date
May 5, 2023
Primary completion
Dec 15, 2025
Completion
Dec 31, 2025
Last update
Aug 14, 2026

Study contacts

Anne Marie Husebø, PhD
principal investigator · University of Stavanger
Ingvild M Morken, PhD
principal investigator · University of Stavanger
Marianne Storm, PhD
principal investigator · University of Stavanger

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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