Nurse-assisted Intervention eHealth@ Hospital -2-home

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Non Communicable Diseases, Heart Failure, Colon Rectal Cancer

Intervention / Treatment
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* Behavioral: eHealth@Hospital-2-Home


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A randomized controlled trial with intervention and control group
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: eHealth@H-2-H<br>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<br>* 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.<br>* Other names: nurse-assisted eHealth intervention on self-management among patients with Non-Communicable Disease;|
| No Intervention: Care as usual<br>The control group will receive care as usual | |

What is the study measuring?
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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) |