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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

November 2, 2011
November 21, 2011
March 2011
August 2011   (final data collection date for primary outcome measure)
SF-36 [ Time Frame: 12 months follow-up ] [ Designated as safety issue: No ]
Questionnaire, 36 questions ref Ware, 2000 version 2
Same as current
Complete list of historical versions of study NCT01478672 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Medium Term Health Coaching and Life-long Monitoring in Cardiovascular Disease in Norrbotten
Medium Term Health Coaching and Life-long Monitoring in Cardiovascular Disease in Norrbotten

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
  • Diabetes
  • Heart Disease
  • Quality of Life
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
  • No Intervention: Standard care
  • Experimental: Health coaching and and Life-long Monitoring
    Intervention: Procedure: Health Coaching and Life-long Monitoring
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
741
September 2011
August 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01478672
LTU-Medium health coaching
Yes
Inger Lindberg, Luleå Tekniska Universitet
Luleå Tekniska Universitet
County Council of Norrbotten, Sweden
Not Provided
Luleå Tekniska Universitet
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP