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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01478672
First Posted: November 23, 2011
Last Update Posted: November 23, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
County Council of Norrbotten, Sweden
Information provided by (Responsible Party):
Inger Lindberg, Luleå Tekniska Universitet
  Purpose
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.

Condition Intervention
Diabetes Heart Disease Quality of Life Procedure: Health Coaching and Life-long Monitoring

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Medium Term Health Coaching and Life-long Monitoring in Cardiovascular Disease in Norrbotten

Further study details as provided by Inger Lindberg, Luleå Tekniska Universitet:

Primary Outcome Measures:
  • SF-36 [ Time Frame: 12 months follow-up ]
    Questionnaire, 36 questions ref Ware, 2000 version 2


Secondary Outcome Measures:
  • 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.

  • Bloodpressure [ Time Frame: 12 months follow-up ]
  • Blood lipids [ Time Frame: 12 months follow-up ]
  • Bodyweight [ Time Frame: 12 months follow-up ]
  • Smoking habits [ Time Frame: 12 months follow-up ]
  • Alcohol consumption [ Time Frame: 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.

  • 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.


Enrollment: 741
Study Start Date: March 2011
Study Completion Date: September 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Standard care
Experimental: Health coaching and and Life-long Monitoring 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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01478672


Locations
Sweden
Luleå University of Technology
Luleå, Sweden, 971 87
Sponsors and Collaborators
Luleå Tekniska Universitet
County Council of Norrbotten, Sweden
  More Information

Additional Information:
Responsible Party: Inger Lindberg, Investigator, Luleå Tekniska Universitet
ClinicalTrials.gov Identifier: NCT01478672     History of Changes
Other Study ID Numbers: LTU-Medium health coaching
First Submitted: November 2, 2011
First Posted: November 23, 2011
Last Update Posted: November 23, 2011
Last Verified: November 2011

Keywords provided by Inger Lindberg, Luleå Tekniska Universitet:
Promotion health

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases