- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01478672
Medium Term Health Coaching and Life-long Monitoring in Cardiovascular Disease in Norrbotten
November 21, 2011 updated by: Inger Lindberg, Luleå Tekniska Universitet
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
741
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Luleå, Sweden, 971 87
- Luleå University of Technology
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Standard care
|
|
Experimental: Health coaching and and Life-long Monitoring
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
SF-36
Time Frame: 12 months follow-up
|
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
Time Frame: 12 months follow-up
|
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
Time Frame: 12 months follow-up
|
12 months follow-up
|
|
Blood lipids
Time Frame: 12 months follow-up
|
12 months follow-up
|
|
Bodyweight
Time Frame: 12 months follow-up
|
12 months follow-up
|
|
Smoking habits
Time Frame: 12 months follow-up
|
12 months follow-up
|
|
Alcohol consumption
Time Frame: 12 months follow-up
|
12 months follow-up
|
|
SOC-13
Time Frame: 12 months follow-up
|
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
Time Frame: 12 monts follow-up
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2011
Primary Completion (Actual)
August 1, 2011
Study Completion (Actual)
September 1, 2011
Study Registration Dates
First Submitted
November 2, 2011
First Submitted That Met QC Criteria
November 21, 2011
First Posted (Estimate)
November 23, 2011
Study Record Updates
Last Update Posted (Estimate)
November 23, 2011
Last Update Submitted That Met QC Criteria
November 21, 2011
Last Verified
November 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- LTU-Medium health coaching
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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