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

Primary Purpose

Non Communicable Diseases, Heart Failure, Colon Rectal Cancer

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
eHealth@Hospital-2-Home
Sponsored by
University of Stavanger
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Non Communicable Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    eHealth@H-2-H

    Care as usual

    Arm Description

    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.

    The control group will receive care as usual

    Outcomes

    Primary Outcome Measures

    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.
    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.

    Secondary Outcome Measures

    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.
    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.
    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.
    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.
    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.
    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).
    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.
    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.
    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.

    Full Information

    First Posted
    November 2, 2022
    Last Updated
    March 16, 2023
    Sponsor
    University of Stavanger
    Collaborators
    Helse Stavanger HF, St. Olavs Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05750953
    Brief Title
    Nurse-assisted Intervention "eHealth@ Hospital -2-home"
    Acronym
    Ehealth@H2H
    Official Title
    Project Title: Nurse Assisted eHealth Service From Hospital to Home: Ameliorating Burden of Treatment Among Patients With Non-Communicable Diseases
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 1, 2023 (Anticipated)
    Primary Completion Date
    June 30, 2024 (Anticipated)
    Study Completion Date
    December 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Stavanger
    Collaborators
    Helse Stavanger HF, St. Olavs Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Non Communicable Diseases, Heart Failure, Colon Rectal Cancer

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    A randomized controlled trial with intervention and control group
    Masking
    Investigator
    Masking Description
    Randomization will be blinded for the researchers performing the data analysis.
    Allocation
    Randomized
    Enrollment
    240 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    eHealth@H-2-H
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Care as usual
    Arm Type
    No Intervention
    Arm Description
    The control group will receive care as usual
    Intervention Type
    Behavioral
    Intervention Name(s)
    eHealth@Hospital-2-Home
    Other Intervention Name(s)
    nurse-assisted eHealth intervention on self-management among patients with Non-Communicable Disease
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Change in patient confidence in self-management activities.
    Description
    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.
    Time Frame
    Baseline (at discharge), post-1 (42 days following baseline, at the end of the intervention), and post-2 (6 months after baseline)
    Title
    Change in heart failure self-care behavior
    Description
    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.
    Time Frame
    Baseline (at discharge), post-1, (42 days following baseline, at the end of the intervention) and post-2 (6 months after baseline)
    Secondary Outcome Measure Information:
    Title
    Change in patient experience with treatment and self-management.
    Description
    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.
    Time Frame
    Baseline (at discharge), post-1(42 days following baseline, at the end of the intervention) , and post-2 (6 months after baseline)
    Title
    Change in patient experience of health condition and how it affects daily life.
    Description
    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.
    Time Frame
    Baseline (at discharge), post-1 (42 days following baseline, at the end of the intervention), and post-2 (6 months after baseline)
    Title
    Change in patient experience of constructive support from healthcare personnel
    Description
    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.
    Time Frame
    Baseline (at discharge), post-1 (42 days following baseline, at the end of the intervention), and post-2 (6 months after baseline)
    Title
    Change in patient experience of shared decision-making.
    Description
    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.
    Time Frame
    Baseline (at discharge), post-1 (42 days following baseline, at the end of the intervention), and post-2 (6 months after baseline)
    Title
    Change in health care utilization
    Description
    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.
    Time Frame
    Baseline (at discharge), post-1 (42 days following baseline, at the end of the intervention), and post-2 (6 months after baseline)
    Title
    Days alive and out of hospital
    Description
    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).
    Time Frame
    Post-2 (6 months after baseline)
    Title
    Number of 30 days readmission for heart failure or colon-rectal cancer related incidents
    Description
    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.
    Time Frame
    Post-1 (42 days following baseline, at the end of the intervention).
    Title
    Number of 90 days readmission for heart failure or colon-rectal cancer related incidents
    Description
    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.
    Time Frame
    Post-2 (6 months following baseline)
    Title
    Number of 12 months readmission for heart failure or colon-rectal cancer related incidents
    Description
    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.
    Time Frame
    Post-3 (12 months following baseline)
    Other Pre-specified Outcome Measures:
    Title
    Change in medication adherence in heart failure patients
    Description
    Change in medication adherence will be measures using the Medication Adherence Reasons Scale-5 (MARS -5) containing 5 items.
    Time Frame
    Post-1 (42 days following baseline, at the end of the intervention), and post-2 (6 months after baseline).
    Title
    Patient satisfaction with using the technology.
    Description
    Patient satisfaction with using the technology will be measured by the Post-Study System Usability Questionnaire. Values: 1-7. Higher score mean worse outcome.
    Time Frame
    Post-1 (42 days following baseline, at the end of the intervention)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Learn more about this trial

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

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