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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Paijat-Hame Hospital District.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Sitra, the Finnish Innovation Fund
Pfizer
University of Tampere
Information provided by:
Paijat-Hame Hospital District
ClinicalTrials.gov Identifier:
NCT00552903
First received: November 1, 2007
Last updated: February 3, 2009
Last verified: February 2009
History of Changes
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]
  • For patients with diabetes: blood HbA1c at target level (7% or less) [ Time Frame: 12 months from start of intervention ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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 Päijät-Häme Central Hospital
Study Chair: Ilmo Parvinen, MD Sitra, the Finnish Innovation Fund
  More Information

No publications provided by Paijat-Hame Hospital District

Additional 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
Study First Received: November 1, 2007
Last Updated: February 3, 2009
Health Authority: Finland: ETENE/TUKIJA
Finland: Medicolegal Board
Finland: Ministry of Health

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

ClinicalTrials.gov processed this record on May 23, 2013