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

Sponsor
Paijat-Hame Hospital District (Other)
Overall Status
Unknown status
CT.gov ID
NCT00552903
Collaborator
Sitra, the Finnish Innovation Fund (Other), Pfizer (Industry), Tampere University (Other)
1,500
Enrollment
1
Location
2
Arms
30
Duration (Months)
50.1
Patients Per Site Per Month

Study Details

Study Description

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
  • Behavioral: Health coaching
 Phase 3

Study Design

Study Type:
Interventional
Anticipated 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 :
Nov 1, 2007
Anticipated Primary Completion Date :
Nov 1, 2009
Anticipated Study Completion Date :
May 1, 2010

Arms and Interventions

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 Names:
  • 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

    Outcome Measures

    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) [12 months from start of intervention]

    2. For patients with diabetes: blood HbA1c at target level (7% or less) [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 [12 months from start of intervention]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    45 Years and Older
    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

    Locations

    Site City State Country Postal Code
    1 Päijät-Hämeen Sosiaali - ja Terveysyhtymä Lahti Finland 15850

    Sponsors and Collaborators

    • Paijat-Hame Hospital District
    • Sitra, the Finnish Innovation Fund
    • Pfizer
    • Tampere University

    Investigators

    • Principal Investigator: Martti Talja, MD, Päijänne Tavastia Central Hospital
    • Study Chair: Ilmo Parvinen, MD, Sitra, the Finnish Innovation Fund

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00552903
    Other Study ID Numbers:
    • PHKS-Z80
    First Posted:
    Nov 2, 2007
    Last Update Posted:
    Feb 4, 2009
    Last Verified:
    Feb 1, 2009
    Additional relevant MeSH terms:
    Heart Diseases
    Coronary Disease
    Diabetes Mellitus
    Diabetes Mellitus, Type 2

    Study Results

    No Results Posted as of Feb 4, 2009