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

This study has been completed.

Sponsor:

Collaborator:

County Council of Norrbotten, Sweden

Information provided by (Responsible Party):

Inger Lindberg, Luleå Tekniska Universitet

ClinicalTrials.gov Identifier:

NCT01478672

First received: November 2, 2011

Last updated: November 21, 2011

Last verified: November 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	November 2, 2011
Last Updated Date	November 21, 2011
Start Date ^ICMJE	March 2011
Primary Completion Date	August 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: November 21, 2011)	SF-36 [ Time Frame: 12 months follow-up ] [ Designated as safety issue: No ] Questionnaire, 36 questions ref Ware, 2000 version 2
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01478672 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: November 21, 2011)	HbA1c (for patients with type-2D) Blood pressure for patient with heart disease [ Time Frame: 12 months follow-up ] [ Designated as safety issue: No ] 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. Bloodpressure [ Time Frame: 12 months follow-up ] [ Designated as safety issue: No ] Blood lipids [ Time Frame: 12 months follow-up ] [ Designated as safety issue: No ] Bodyweight [ Time Frame: 12 months follow-up ] [ Designated as safety issue: No ] Smoking habits [ Time Frame: 12 months follow-up ] [ Designated as safety issue: No ] Alcohol consumption [ Time Frame: 12 months follow-up ] [ Designated as safety issue: No ] SOC-13 [ Time Frame: 12 months follow-up ] [ Designated as safety issue: No ] 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. EQ-5D [ Time Frame: 12 monts follow-up ] [ Designated as safety issue: No ] 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.
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Medium Term Health Coaching and Life-long Monitoring in Cardiovascular Disease in Norrbotten
Official Title ^ICMJE	Medium Term Health Coaching and Life-long Monitoring in Cardiovascular Disease in Norrbotten
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Investigator, Outcomes Assessor) Primary Purpose: Supportive Care
Condition ^ICMJE	Diabetes Heart Disease Quality of Life
Intervention ^ICMJE	Procedure: Health Coaching 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
Study Arm (s)	No Intervention: Standard care Experimental: Health coaching and and Life-long Monitoring Intervention: Procedure: Health Coaching and Life-long Monitoring
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	741
Completion Date	September 2011
Primary Completion Date	August 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Sweden

Administrative Information
NCT Number ^ICMJE	NCT01478672
Other Study ID Numbers ^ICMJE	LTU-Medium health coaching
Has Data Monitoring Committee	Yes
Responsible Party	Inger Lindberg, Luleå Tekniska Universitet
Study Sponsor ^ICMJE	Luleå Tekniska Universitet
Collaborators ^ICMJE	County Council of Norrbotten, Sweden
Investigators ^ICMJE	Not Provided
Information Provided By	Luleå Tekniska Universitet
Verification Date	November 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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