Nurse-assisted Intervention "eHealth@ Hospital -2-home" (Ehealth@H2H)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure; Colon Rectal Cancer; Non Communicable Diseases
• Intervention / Treatment: Behavioral: eHealth@Hospital-2-Home

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.

• Study Type: Interventional
• Enrollment (Estimated): 240
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anne Marie L Husebø, PhD; Phone Number: 004799262805; Email: anne.m.husebo@uis.no

Study Locations

• Norway
  • Rogaland
    • Stavanger, Rogaland, Norway, 4036
      • Recruiting
      • Anne Marie Lunde Husebø
      • Contact: Svein Scheie, MD, PhD; Email: svein.skeie@sus.no
      • Contact: Marianne Storm, PhD; Phone Number: Storm 004748133750; Email: marianne.storm@uis.no
      • Sub-Investigator: Marianne Storm, PhD
      • Principal Investigator: Ingvild M Morken, PhD
      • Principal Investigator: Anne Marie L Husebø, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: eHealth@H-2-H; The intervention group will participate in a 42-day nurse-assisted 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; 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
No Intervention: Care as usual; The control group will receive care as usual

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
Change in heart failure self-care behavior	Change in heart failure patients' self-care behavior between baseline and post-1 and 2 will be measured by use of the European Heart Failure Self-care Behavior Scale. Value: 1-5. Higher score mean worse outcome.	Baseline (at discharge), post-1, (42 days following baseline, at the end of the intervention) and post-2 (6 months after baseline)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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	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.	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.	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.	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	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.	Baseline (at discharge), post-1 (42 days following baseline, at the end of the intervention), and post-2 (6 months after baseline)
Days alive and out of hospital	Days alive and out of hospital will be measured by patient's self-report against data from hospital records, and calculated by subtracting number of days spent away from home due to heart failure or colon-rectal cancer related hospitalization from the day of the first reporting in the patient application and the six months following (post 2).	Post-2 (6 months after baseline)
Number of 30 days readmission for heart failure or colon-rectal cancer related incidents	Numbers of 30-days readmission for Heart failure or Colon-rectal cancer related incidents will be collected from the electronic health care record system in the hospital.	Post-1 (42 days following baseline, at the end of the intervention).
Number of 90 days readmission for heart failure or colon-rectal cancer related incidents	Numbers of 30-days readmission for heart failure or colon-rectal cancer related incidents will be collected from the electronic health care record system in the hospital.	Post-2 (6 months following baseline)
Number of 12 months readmission for heart failure or colon-rectal cancer related incidents	Numbers of 12-months readmission for heart failure or colon-rectal cancer related incidents will be collected from the electronic health care record system in the hospital.	Post-3 (12 months following baseline)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in medication adherence in heart failure patients	Change in medication adherence will be measures using the Medication Adherence Reasons Scale-5 (MARS -5) containing 5 items.	Post-1 (42 days following baseline, at the end of the intervention), and post-2 (6 months after baseline).
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.	Post-1 (42 days following baseline, at the end of the intervention)

Collaborators and Investigators

• Sponsor: University of Stavanger
• Collaborators: Helse Stavanger HF; St. Olavs Hospital
• Investigators: Principal Investigator: Anne Marie Husebø, PhD, University of Stavanger; Principal Investigator: Ingvild M Morken, PhD, University of Stavanger; Principal Investigator: Marianne Storm, PhD, University of Stavanger

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2023
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: November 2, 2022
• First Submitted That Met QC Criteria: February 27, 2023
• First Posted (Actual): March 2, 2023

Study Record Updates

• Last Update Posted (Estimated): December 5, 2023
• Last Update Submitted That Met QC Criteria: December 4, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Noncommunicable Diseases
• Other Study ID Numbers: 301472

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No