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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

November 1, 2007
February 3, 2009
November 2007
November 2009   (final data collection date for primary outcome measure)
  • 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 ]
  • 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 ]
Complete list of historical versions of study NCT00552903 on ClinicalTrials.gov Archive Site
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 ]
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 ]
Not Provided
Not Provided
 
Randomised Trial of Health Coaching in Secondary Prevention of Diabetes and Heart Disease
Randomised Trial of Health Coaching in Secondary Prevention of Diabetes and Heart Disease

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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Diabetes Mellitus, Type 2
  • Heart Failure
  • Coronary Disease
Behavioral: Health coaching
Personal health coach providing advice and counselling by telephone, weekly contacts
Other Name: Counseling, health education
  • Experimental: 1
    Active intervention - personal health coaching provided
    Intervention: Behavioral: Health coaching
  • 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
Patja K, Absetz P, Auvinen A, Tokola K, Kytö J, Oksman E, Kuronen R, Ovaska T, Harno K, Nenonen M, Wiklund T, Kettunen R, Talja M. Health coaching by telephony to support self-care in chronic diseases: clinical outcomes from The TERVA randomized controlled trial. BMC Health Serv Res. 2012 Jun 10;12:147. doi: 10.1186/1472-6963-12-147.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1500
May 2010
November 2009   (final data collection date for primary outcome measure)

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
Both
45 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Finland
 
NCT00552903
PHKS-Z80
Not Provided
Dr Martti Talja, Päijät-Häme Health and Welfare Trust
Paijat-Hame Hospital District
  • Sitra, the Finnish Innovation Fund
  • Pfizer
  • University of Tampere
Principal Investigator: Martti Talja, MD Päijät-Häme Central Hospital
Study Chair: Ilmo Parvinen, MD Sitra, the Finnish Innovation Fund
Paijat-Hame Hospital District
February 2009

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