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

February 3, 2009 updated by: Paijat-Hame Hospital District
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

1500

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Lahti, Finland, 15850
        • Päijät-Hämeen Sosiaali - ja Terveysyhtymä

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
12 months from start of intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
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
12 months from start of intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Paijat-Hame Hospital District

Collaborators

Pfizer
Tampere University
Sitra, the Finnish Innovation Fund

Investigators

  • Principal Investigator: Martti Talja, MD, Päijät-Häme Central Hospital
  • Study Chair: Ilmo Parvinen, MD, Sitra, the Finnish Innovation Fund

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Anticipated)

November 1, 2009

Study Completion (Anticipated)

May 1, 2010

Study Registration Dates

First Submitted

November 1, 2007

First Submitted That Met QC Criteria

November 1, 2007

First Posted (Estimate)

November 2, 2007

Study Record Updates

Last Update Posted (Estimate)

February 4, 2009

Last Update Submitted That Met QC Criteria

February 3, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PHKS-Z80

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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