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Active, Not Recruiting

NCT Number: NCT05750953

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Non Communicable Diseases Cardiovascular Diseases Colon Rectal Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Disease Attributes Gastrointestinal Diseases Gastrointestinal Neoplasms Heart Diseases Heart Failure Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Noncommunicable Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Anne Marie Lunde Husebø

Stavanger, Rogaland, 4036, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

eHealth@Hospital-2-Home

Behavioral

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.

Other names: nurse-assisted eHealth intervention on self-management among patients with Non-Communicable Disease

Primary outcomes

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

    Time frame: 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 outcomes

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

  5. Change in health care utilization

    Time frame: 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.

  6. Days alive and out of hospital

    Time frame: 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.

  7. Time to first readmission or death

    Time frame: 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.

Other outcomes

  1. Patient satisfaction with using the technology.

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

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

Sponsors and collaborators

Lead sponsor

University of Stavanger

Other

Collaborators

  • Helse Stavanger HF
  • St. Olavs Hospital

Registry information

Official study title

Project Title: Nurse Assisted eHealth Service From Hospital to Home: Ameliorating Burden of Treatment Among Patients With Non-Communicable Diseases

Acronym: Ehealth@H2H

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 2, 2023
Registry last updated
Aug 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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