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

NCT05750953 | Active Not Recruiting DMC

• 1 other identifier: 301472
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

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.

Conditions

Non Communicable Diseases; Heart Failure; Colon Rectal Cancer

Outcome Measures

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.

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

Secondary Outcomes (7)

• 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 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 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 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 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)

Other Outcomes (1)

• Patient satisfaction with using the technology.

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

Study Arms (2)

eHealth@H-2-H

EXPERIMENTAL

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

Care as usual

NO INTERVENTION

The control group will receive care as usual

Interventions

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.

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

eHealth@H-2-H

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Stavanger: lead
• Helse Stavanger HF: collaborator
• St. Olavs Hospital: collaborator

Study Sites (1)

Anne Marie Lunde Husebø

Stavanger, Rogaland, 4036, Norway

Location

MeSH Terms

Conditions

Noncommunicable Diseases; Heart Failure; Colonic Neoplasms

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Anne Marie Husebø, PhD

  University of Stavanger

  PRINCIPAL INVESTIGATOR

• Ingvild M Morken, PhD

  University of Stavanger

  PRINCIPAL INVESTIGATOR

• Marianne Storm, PhD

  University of Stavanger

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Randomization will be blinded for the study statistician and researchers performing the data analysis.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A randomized controlled trial with intervention and control group

Study Record Dates

• First Submitted: November 2, 2022
• First Posted: March 2, 2023
• Study Start: May 5, 2023
• Primary Completion: December 15, 2025
• Study Completion: December 31, 2025
• Last Updated: August 17, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)