Type 2 DiabetesNCT01310491
RENEWING HEALTH - RegioNs of Europe WorkINg Together for HEALTH
A study testing Health coaching in people with Type 2 Diabetes and Coronary Artery Disease, run by South Karelia, Social and Health Care District at 1 site in Finland.
Trial summary
The purpose of this trial is to determine if by structured telephone based health coaching programme supported by remote monitoring system among type 2 diabetes, coronary artery disease and heart failure patients the investigators are able to improve their quality of life as measured by the SF-36 questionnaire and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes, Coronary Artery Disease, Heart Failure
- 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
- 595 participants
- Where
- 1 siteFinland
- Study dates
- Feb 2011to Dec 2012
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Capability of filling in questionnaires in Finnish language.
- Be able to use Remote Patient Monitoring System
- Be able to use the devices provided
- Has adequate cognitive capacities to participate
- In their medical records, one or both of the following diagnoses:
Show all 14Show fewer
- Type 2 Diabetes, for enrolment
- diagnosed over 3 months prior to the enrolment and
- HbA1c > 6,5 % b) Heart Disease, for enrolment
- Ischemic heart disease or
- Heart Failure or
- Atrial fibrillation or
- Other arrhythmia
- Be able to walk
Who cannot join
- Not willing to participate (e.g., not willing to sign the consent)
Trial locations and contacts
1 site in 1 country.
Finland1 site
Etelä-Karjalan sosiaali- ja terveydenhuollon kuntayhtymä
Lappeenranta, 53100
About this study
Official title: RENEWING HEALTH Large-scale Real-life Study in Finland
The purpose of this trial is to determine if by structured telephone based health coaching programme supported by remote monitoring system among type 2 diabetes, coronary artery disease and heart failure patients the investigators are able to improve their quality of life as measured by the SF-36 questionnaire and reduce a value of HbA1c under 6,5 % among those type 2 diabetes patients who had elevated value of HbA1c when recruited.
Read the detailed description
RENEWING HEALTH is a project covering 9 different European States. It aims at evaluation of innovative telemedicine services using a patient-centred approach and a common rigorous assessment methodology. In 9 European regions in the implementation of health-related information and communication technologies service solutions are already operational at local level for the remote monitoring and the treatment of chronic patients suffering from diabetes,chronic obstructive pulmonary disease or cardiovascular diseases. The services are designed to give patients a central role in the management of their own diseases, fine-tuning the choice and dosage of medications, promoting compliance to treatment, and helping health care professionals to detect early signs of worsening in the monitored pathologies. Every area will designed its own real-life trial with certain common elements.
- Conditions
- Type 2 Diabetes, Coronary Artery Disease, Heart Failure, Atrial Fibrillation, Other Arrhythmias
- Being tested
- Health coaching
- Medical subject headings
- Diabetes Mellitus, Type 2, Coronary Artery Disease, Heart Failure, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health coachingBehavioural
Telephone based health coaching supported by tele-monitoring.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Not described Receives: Behavioral: Health coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health related quality of life
Health related quality of life is assessed by the SF-36 questionnaire.
Measured: 12 months
HbA1c change over time (participants with T2DM only)
Measured: 12 months
Secondary outcomes (8)
Medication compliance
Measured: 12 months
Blood pressure reduction
Measured: 12 months
Weight reduction
Measured: 12 months
Activity increase
Measured: 12 months
Smoke cessation
Measured: 12 months
Alcohol use reduction
Measured: 12 months
Cost for the organization
Measured: 12 months
Satisfaction and usability of the technology and equipments.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2011 (estimated)
- Study startFeb 2011
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 595 participants (actual)
Sponsor and investigators
- Lead sponsor
- South Karelia, Social and Health Care District
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tuula Karhula, South Karelia, Social and Health Care District
- Investigators
- Tuula Karhula, MD, PhD, Principal investigator, South Karelia social and health district
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01310491
- Sponsor's protocol ID
- Renewing Health WP WP 13 Fin
- Status last verified
- Feb 2014
- First submitted
- 7 Mar 2011
- Last updated
- 17 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Karhula T, Vuorinen AL, Raapysjarvi K, Pakanen M, Itkonen P, Tepponen M, Junno UM, Jokinen T, van Gils M, Lahteenmaki J, Kohtamaki K, Saranummi N. Telemonitoring and Mobile Phone-Based Health Coaching Among Finnish Diabetic and Heart Disease Patients: Randomized Controlled Trial. J Med Internet Res. 2015 Jun 17;17(6):e153. doi: 10.2196/jmir.4059.
PubMed 26084979
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RENEWING HEALTH Large-scale Real-life Study in Finland
- ClinicalTrials.gov ID
- NCT01310491
- Acronym / sponsor ID
- Renewing Health WP WP 13 Fin
- Conditions
- Type 2 Diabetes, Coronary Artery Disease, Heart Failure, Atrial Fibrillation, Other Arrhythmias
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 595 participants (actual)
- Lead sponsor
- South Karelia, Social and Health Care DistrictUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 8 Mar 2011 (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.
The purpose of this trial is to determine if by structured telephone based health coaching programme supported by remote monitoring system among type 2 diabetes, coronary artery disease and heart failure patients the investigators are able to improve their quality of life as measured by the SF-36 questionnaire and reduce a value of HbA1c under 6,5 % among those type 2 diabetes patients who had elevated value of HbA1c when recruited.
Detailed description
RENEWING HEALTH is a project covering 9 different European States. It aims at evaluation of innovative telemedicine services using a patient-centred approach and a common rigorous assessment methodology. In 9 European regions in the implementation of health-related information and communication technologies service solutions are already operational at local level for the remote monitoring and the treatment of chronic patients suffering from diabetes,chronic obstructive pulmonary disease or cardiovascular diseases. The services are designed to give patients a central role in the management of their own diseases, fine-tuning the choice and dosage of medications, promoting compliance to treatment, and helping health care professionals to detect early signs of worsening in the monitored pathologies. Every area will designed its own real-life trial with certain common elements.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | Behavioral: Health coaching |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Age > 18 years
- Capability of filling in questionnaires in Finnish language.
- Be able to use Remote Patient Monitoring System
- Be able to use the devices provided
- Has adequate cognitive capacities to participate
Key exclusion criteria (1 listed)
- Not willing to participate (e.g., not willing to sign the consent)
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 coachingTelephone based health coaching supported by tele-monitoring. | Behavioural | Usual Care |
Primary outcome
Health related quality of life
Time frame: 12 months
Health related quality of life is assessed by the SF-36 questionnaire.
HbA1c change over time (participants with T2DM only)
Time frame: 12 months
8 secondary outcomes
Medication compliance
Time frame: 12 months
Blood pressure reduction
Time frame: 12 months
Weight reduction
Time frame: 12 months
Activity increase
Time frame: 12 months
Smoke cessation
Time frame: 12 months
Alcohol use reduction
Time frame: 12 months
Cost for the organization
Time frame: 12 months
Satisfaction and usability of the technology and equipments.
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2014.
- Derived from this study: PubMed 26084979Karhula T, Vuorinen AL, Raapysjarvi K, Pakanen M, Itkonen P, Tepponen M, Junno UM, Jokinen T, van Gils M, Lahteenmaki J, Kohtamaki K, Saranummi N. Telemonitoring and Mobile Phone-Based Health Coaching Among Finnish Diabetic and Heart Disease Patients: Randomized Controlled Trial. J Med Internet Res. 2015 Jun 17;17(6):e153. doi: 10.2196/jmir.4059.
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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.
Tuula Karhula, MD, PhD principal investigator
South Karelia social and health district
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health coaching in people with Type 2 Diabetes and Coronary Artery Disease, run by South Karelia, Social and Health Care 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 14 inclusion and 1 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: finished, as of the sponsor's last update on 17 Feb 2014. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Health related quality of life (time frame: 12 months). 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 NCT01310491, which also lists 1 linked publication.
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 17 Feb 2014.