Medium Term Health Coaching and Life-long Monitoring in Cardiovascular Disease in Norrbotten

Study Overview
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Brief Summary
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The purpose of this study is to evaluate whether the introduction of large-scale personalized and technology supported telemonitoring and health coaching interventions produces benefits in terms of health related quality of life, health status and empowerment of patients with a cardiovascular disease. In addition, the trials evaluate the economical and organizational impact of the new services and examine their acceptability by patients and health professionals.

Official Title
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Medium Term Health Coaching and Life-long Monitoring in Cardiovascular Disease in Norrbotten

Conditions
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Diabetes, Heart Disease, Quality of Life

Intervention / Treatment
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* Procedure: Health Coaching and Life-long Monitoring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of arterial hypertension ischemic heart disease, atrial fibrillation or other arrhythmia, congestive heart failure (study heart disease) HbA1C > 53mmol/mol (study diabetes) Age > 18 years Capability of filling in questionnaires in the own language Capability to use the devices provided Being cognitively able to participate

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard care<br> | |
| Experimental: Health coaching and and Life-long Monitoring<br> | Procedure: Health Coaching and Life-long Monitoring<br>* Participants receive tablet PCs with software that collects and transmit diagnostic measurements. Measurements are performed by the participants following indications of the health coaching team. Equipment used by all participants: • blood pressure meter, • pedometer • pulse watch• 2-channel electrocardiograph. Measured values are entered manually by the participants, unrealistic values are refused and values are provided with a time-stamp. Measurements is reviewed in a graphical display. Measured values are accessed by the health coaching team that develops an individualized measurement and medication scheme. Reminders are provided by the software and can be exported to personal calendars or mobile phones. Secure authentication of users is be provided<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SF-36 | Questionnaire, 36 questions ref Ware, 2000 version 2 | 12 months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c (for patients with type-2D) Blood pressure for patient with heart disease | HbA1c is a long-term sugar / serum glucose test, it is a blood test that gives a measure of blood sugar levels two to three months before sampling. | 12 months follow-up | 
| Bloodpressure |  | 12 months follow-up | 
| Blood lipids |  | 12 months follow-up | 
| Bodyweight |  | 12 months follow-up | 
| Smoking habits |  | 12 months follow-up | 
| Alcohol consumption |  | 12 months follow-up | 
| SOC-13 | SOC-13 (sense of coherence, SOC) is a term that reflects the ability to cope with stress and is the essence of the salutogenic theory of health. SOC consists of three subordinate concepts, manageability, meaningfulness and comprehensibility. | 12 months follow-up | 
| EQ-5D | EQ5D (5d) is a standardized instrument to measure and describe health outcomes. It can be used to measure health at the individual level in clinical settings and to measure a population's health locally and nationally. | 12 monts follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Promotion health