Diabetes Mellitus, Type 2Phase 3TerVaNCT00552903
Randomised Trial of Health Coaching in Secondary Prevention of Diabetes and Heart Disease
A Phase 3 study testing Health coaching in people with Diabetes Mellitus, Type 2 and Heart Failure, run by Paijat-Hame Hospital District at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2, Heart Failure, Coronary Disease
- What is being tested?
- Health coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 1 siteFinland
- Study dates
- Nov 2007to May 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Diabetes Mellitus, Type 2, Heart Failure, Coronary Disease
- Being tested
- Health coaching
- Medical subject headings
- Diabetes Mellitus, Type 2, Heart Failure, Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health coachingBehavioural
Also called Counseling, health education
Personal health coach providing advice and counselling by telephone, weekly contacts
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Active intervention - personal health coaching provided Receives: Behavioral: Health coaching |
| 2 | No intervention | Control arm - no intervention, data on health outcomes collected at baseline (entry to the study) and during the 12 month follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 12 months from start of intervention
For patients with diabetes: blood HbA1c at target level (7% or less)
Measured: 12 months from start of intervention
Secondary outcomes (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
Measured: 12 months from start of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2007 (estimated)
- Study startNov 2007
- Primary completionNov 2009 (estimated)
- Study completionMay 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Paijat-Hame Hospital District
- Sponsor type
- University, hospital or other
- Collaborators
- Sitra, the Finnish Innovation Fund, Pfizer, Tampere University
- Investigators
- Martti Talja, MD, Principal investigator, Päijät Häme Central HospitalIlmo Parvinen, MD, Study chair, Sitra, the Finnish Innovation Fund
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00552903
- Sponsor's protocol ID
- PHKS-Z80
- Acronym
- TerVa
- Status last verified
- Feb 2009
- First submitted
- 1 Nov 2007
- Last updated
- 4 Feb 2009
- Results posted
- No
Publications
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.
PubMed 34781936Mustonen 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.
PubMed 31884682Oksman 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.
PubMed 28202032Patja 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.
PubMed 22682298
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Trial of Health Coaching in Secondary Prevention of Diabetes and Heart Disease
- ClinicalTrials.gov ID
- NCT00552903
- Acronym / sponsor ID
- TerVa / PHKS-Z80
- Conditions
- Diabetes Mellitus, Type 2, Heart Failure, Coronary Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Paijat-Hame Hospital DistrictUniversity, hospital or other
- Collaborators
- Sitra, the Finnish Innovation Fund, Pfizer, Tampere University
- Study start
- Nov 2007
- Primary completion
- Nov 2009 (estimated)
- Study completion
- May 2010 (estimated)
- First posted
- 2 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Health coachingActive intervention - personal health coaching provided |
| 2 | No intervention | –Control arm - no intervention, data on health outcomes collected at baseline (entry to the study) and during the 12 month follow-up |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health coachingAlso: Counseling, health educationPersonal health coach providing advice and counselling by telephone, weekly contacts | Behavioural | 1 |
Primary outcome
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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2009.
- Derived from this study: PubMed 34781936Mustonen 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.
- Derived from this study: PubMed 31884682Mustonen 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.
- Derived from this study: PubMed 28202032Oksman 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.
- Derived from this study: PubMed 22682298Patja 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martti Talja, MD principal investigator
Päijät Häme Central Hospital
Ilmo Parvinen, MD study chair
Sitra, the Finnish Innovation Fund
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Health coaching in people with Diabetes Mellitus, Type 2 and Heart Failure, run by Paijat-Hame Hospital District at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00552903, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2009.