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

Not Applicable
Recruiting
Conditions
Non Communicable Diseases
Colon Rectal Cancer
Heart Failure
Interventions
Behavioral: eHealth@Hospital-2-Home
Registration Number
NCT05750953
Lead Sponsor
University of Stavanger
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.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
240
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
eHealth@H-2-HeHealth@Hospital-2-HomeThe 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.
Primary Outcome Measures
NameTimeMethod
Change in patient confidence in self-management activities.Baseline (at discharge), post-1 (42 days following baseline, at the end of the intervention), and post-2 (6 months after baseline)

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 behaviorBaseline (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 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
NameTimeMethod
Change in patient experience of constructive support from healthcare personnelBaseline (at discharge), post-1 (42 days following baseline, at the end of the intervention), and post-2 (6 months after baseline)

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.

Number of 90 days readmission for heart failure or colon-rectal cancer related incidentsPost-2 (6 months following baseline)

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.

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 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 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 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.

Number of 30 days readmission for heart failure or colon-rectal cancer related incidentsPost-1 (42 days following baseline, at the end of the intervention).

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.

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 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 health care utilizationBaseline (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 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 hospitalPost-2 (6 months after baseline)

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 12 months readmission for heart failure or colon-rectal cancer related incidentsPost-3 (12 months following baseline)

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.

Trial Locations

Locations (1)

Anne Marie Lunde Husebø

🇳🇴

Stavanger, Rogaland, Norway

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