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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Medium Term Health Coaching and Life-long Monitoring in Cardiovascular Disease in Norrbotten

Resource links provided by NLM:


Further study details as provided by Luleå Tekniska Universitet:

Primary Outcome Measures:
  • SF-36 [ Time Frame: 12 months follow-up ] [ Designated as safety issue: No ]
    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 ] [ 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.


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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Inger Lindberg, Investigator, Luleå Tekniska Universitet
ClinicalTrials.gov Identifier: NCT01478672     History of Changes
Other Study ID Numbers: LTU-Medium health coaching
Study First Received: November 2, 2011
Last Updated: November 21, 2011
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Luleå Tekniska Universitet:
Promotion health

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on August 28, 2014