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

NCT00552903

Last updated date
Study Location
Päijät-Hämeen Sosiaali - ja Terveysyhtymä
Lahti, , 15850, Finland
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Type 2 Diabetes Mellitus, Heart Failure, Coronary Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
45 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Type 2 Diabetes Mellitus, Heart Failure, Coronary DiseaseRandomised Trial of Health Coaching in Secondary Prevention of Diabetes and Heart Disease
NCT00552903
  1. Lahti,
ALL GENDERS
45 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Randomised Trial of Health Coaching in Secondary Prevention of Diabetes and Heart Disease
Official Title  ICMJE Randomised Trial of Health Coaching in Secondary Prevention of Diabetes and Heart Disease
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Diabetes Mellitus, Type 2
  • Heart Failure
  • Coronary Disease
Intervention  ICMJE Behavioral: Health coaching
Personal health coach providing advice and counselling by telephone, weekly contacts
Other Name: Counseling, health education
Study Arms  ICMJE
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 1, 2007)
1500
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2010
Estimated Primary Completion Date November 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 45 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Finland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00552903
Other Study ID Numbers  ICMJE PHKS-Z80
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr Martti Talja, Päijät-Häme Health and Welfare Trust
Study Sponsor  ICMJE Paijat-Hame Hospital District
Collaborators  ICMJE
  • Sitra, the Finnish Innovation Fund
  • Pfizer
  • Tampere University
Investigators  ICMJE
Principal Investigator:Martti Talja, MDPäijänne Tavastia Central Hospital
Study Chair:Ilmo Parvinen, MDSitra, the Finnish Innovation Fund
PRS Account Paijat-Hame Hospital District
Verification Date February 2009

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