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Randomised Trial of Health Coaching in Secondary Prevention of Diabetes and Heart Disease (TerVa)

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ClinicalTrials.gov Identifier: NCT00552903
Recruitment Status : Unknown
Verified February 2009 by Paijat-Hame Hospital District.
Recruitment status was:  Active, not recruiting
First Posted : November 2, 2007
Last Update Posted : February 4, 2009
Sponsor:
Collaborators:
Sitra, the Finnish Innovation Fund
Pfizer
University of Tampere
Information provided by:
Paijat-Hame Hospital District

Brief Summary:
A randomised trial with individual patients as units of observation will be carried out. Health coaching is used to modify health behaviour and thus improve disease control and health status, as well as use of health care services. A personal health coach is assigned to each patient and they are in weekly contact through telephone. The intervention lasts for 12 months. No intervention is offered to the patients in the control arm.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Heart Failure Coronary Disease Behavioral: Health coaching Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Randomised Trial of Health Coaching in Secondary Prevention of Diabetes and Heart Disease
Study Start Date : November 2007
Estimated Primary Completion Date : November 2009
Estimated Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Active intervention - personal health coaching provided
Behavioral: Health coaching
Personal health coach providing advice and counselling by telephone, weekly contacts
Other Name: Counseling, health education
No Intervention: 2
Control arm - no intervention, data on health outcomes collected at baseline (entry to the study) and during the 12 month follow-up



Primary Outcome Measures :
  1. Blood pressure at target level (140/85 or lower), total cholesterol at target level (4.5 mmol/l or lower), LDL cholesterol at target level (2.5 mmol/l or below), waist circumference at target level (<=94 men, <=80 cm women) [ Time Frame: 12 months from start of intervention ]
  2. For patients with diabetes: blood HbA1c at target level (7% or less) [ Time Frame: 12 months from start of intervention ]

Secondary Outcome Measures :
  1. Improvement in body mass index, health-related quality of life (15D instrument), amount of exercise, diet, smoking cessation; for patients with heart failure also use of emergency services and NYHA class [ Time Frame: 12 months from start of intervention ]


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Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of type 2 diabetes (medication and HbA1c>7% and no cardiovascular disease), coronary artery disease (history of myocardial infarction or revascularisation) or heart failure (NYHA II-III and admitted in a hospital for the condition within 2 years)
  • Aged 45 years or older
  • Resident in the Päijät-Häme health care district

Exclusion Criteria:

  • Classified as ineligible by primary care physician
  • Unable to co-operate or participate in health coaching
  • Major elective surgery planned within 6 months
  • History of major surgery within past 2 years
  • Life expectancy <1 year
  • Pregnancy

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): NCT00552903


Locations
Finland
Päijät-Hämeen Sosiaali - ja Terveysyhtymä
Lahti, Finland, 15850
Sponsors and Collaborators
Paijat-Hame Hospital District
Sitra, the Finnish Innovation Fund
Pfizer
University of Tampere
Investigators
Principal Investigator: Martti Talja, MD Päijänne Tavastia Central Hospital
Study Chair: Ilmo Parvinen, MD Sitra, the Finnish Innovation Fund

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr Martti Talja, Päijät-Häme Health and Welfare Trust
ClinicalTrials.gov Identifier: NCT00552903     History of Changes
Other Study ID Numbers: PHKS-Z80
First Posted: November 2, 2007    Key Record Dates
Last Update Posted: February 4, 2009
Last Verified: February 2009

Additional relevant MeSH terms:
Diabetes Mellitus
Heart Failure
Heart Diseases
Diabetes Mellitus, Type 2
Coronary Disease
Coronary Artery Disease
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Cardiovascular Diseases
Myocardial Ischemia
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases