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

Primary Purpose

Diabetes Mellitus, Type 2, Heart Failure, Coronary Disease

Status
Unknown status
Phase
Phase 3
Locations
Finland
Study Type
Interventional
Intervention
Health coaching
Sponsored by
Paijat-Hame Hospital District
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetes Mellitus, Type 2

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Päijät-Hämeen Sosiaali - ja Terveysyhtymä

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

1

2

Arm Description

Active intervention - personal health coaching provided

Control arm - no intervention, data on health outcomes collected at baseline (entry to the study) and during the 12 month follow-up

Outcomes

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)
For patients with diabetes: blood HbA1c at target level (7% or less)

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

Full Information

First Posted
November 1, 2007
Last Updated
February 3, 2009
Sponsor
Paijat-Hame Hospital District
Collaborators
Sitra, the Finnish Innovation Fund, Pfizer, Tampere University
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1. Study Identification

Unique Protocol Identification Number
NCT00552903
Brief Title
Randomised Trial of Health Coaching in Secondary Prevention of Diabetes and Heart Disease
Acronym
TerVa
Official Title
Randomised Trial of Health Coaching in Secondary Prevention of Diabetes and Heart Disease
Study Type
Interventional

2. Study Status

Record Verification Date
February 2009
Overall Recruitment Status
Unknown status
Study Start Date
November 2007 (undefined)
Primary Completion Date
November 2009 (Anticipated)
Study Completion Date
May 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Paijat-Hame Hospital District
Collaborators
Sitra, the Finnish Innovation Fund, Pfizer, Tampere University

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Heart Failure, Coronary Disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Active intervention - personal health coaching provided
Arm Title
2
Arm Type
No Intervention
Arm Description
Control arm - no intervention, data on health outcomes collected at baseline (entry to the study) and during the 12 month follow-up
Intervention Type
Behavioral
Intervention Name(s)
Health coaching
Other Intervention Name(s)
Counseling, health education
Intervention Description
Personal health coach providing advice and counselling by telephone, weekly contacts
Primary Outcome Measure Information:
Title
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
Title
For patients with diabetes: blood HbA1c at target level (7% or less)
Time Frame
12 months from start of intervention
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martti Talja, MD
Organizational Affiliation
Päijät Häme Central Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ilmo Parvinen, MD
Organizational Affiliation
Sitra, the Finnish Innovation Fund
Official's Role
Study Chair
Facility Information:
Facility Name
Päijät-Hämeen Sosiaali - ja Terveysyhtymä
City
Lahti
ZIP/Postal Code
15850
Country
Finland

12. IPD Sharing Statement

Citations:
PubMed Identifier
34781936
Citation
Mustonen E, Horhammer I, Patja K, Absetz P, Lammintakanen J, Talja M, Kuronen R, Linna M. Eight-year post-trial follow-up of morbidity and mortality of telephone health coaching. BMC Health Serv Res. 2021 Nov 15;21(1):1237. doi: 10.1186/s12913-021-07263-w.
Results Reference
derived
PubMed Identifier
31884682
Citation
Mustonen E, Horhammer I, Absetz P, Patja K, Lammintakanen J, Talja M, Kuronen R, Linna M. Eight-year post-trial follow-up of health care and long-term care costs of tele-based health coaching. Health Serv Res. 2020 Apr;55(2):211-217. doi: 10.1111/1475-6773.13251. Epub 2019 Dec 29.
Results Reference
derived
PubMed Identifier
28202032
Citation
Oksman E, Linna M, Horhammer I, Lammintakanen J, Talja M. Cost-effectiveness analysis for a tele-based health coaching program for chronic disease in primary care. BMC Health Serv Res. 2017 Feb 15;17(1):138. doi: 10.1186/s12913-017-2088-4.
Results Reference
derived
PubMed Identifier
22682298
Citation
Patja K, Absetz P, Auvinen A, Tokola K, Kyto 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.
Results Reference
derived

Learn more about this trial

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

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