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| Name | Class |
|---|---|
| Helse Stavanger HF | OTHER_GOV |
| St. Olavs Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Care as usual | No Intervention | The control group will receive care as usual |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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) |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anne Marie Lunde Husebø | Stavanger | Rogaland | 4036 | Norway |
According to legal and ethical legislation and approvals.
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| ID | Term |
|---|---|
| D000073296 | Noncommunicable Diseases |
| D006333 | Heart Failure |
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006331 | Heart Diseases |
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A randomized controlled trial with intervention and control group
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Randomization will be blinded for the study statistician and researchers performing the data analysis.
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| 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 (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. | Post-2 (6 months after baseline) |
| 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 of first readmission within six months or death |
| D002318 | Cardiovascular Diseases |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |