This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2009 by Paijat-Hame Hospital District.
Recruitment status was:  Active, not recruiting
Sitra, the Finnish Innovation Fund
University of Tampere
Information provided by:
Paijat-Hame Hospital District Identifier:
First received: November 1, 2007
Last updated: February 3, 2009
Last verified: February 2009
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 Intervention Phase
Diabetes Mellitus, Type 2 Heart Failure Coronary Disease Behavioral: Health coaching Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Paijat-Hame Hospital District:

Primary Outcome Measures:
  • 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 ]
  • For patients with diabetes: blood HbA1c at target level (7% or less) [ Time Frame: 12 months from start of intervention ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 1500
Study Start Date: November 2007
Estimated Study Completion Date: May 2010
Estimated Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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

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
  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 identifier: NCT00552903

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Dr Martti Talja, Päijät-Häme Health and Welfare Trust Identifier: NCT00552903     History of Changes
Other Study ID Numbers: PHKS-Z80
Study First Received: November 1, 2007
Last Updated: February 3, 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
Arterial Occlusive Diseases processed this record on September 21, 2017