DiabetesNCT01478672
Medium Term Health Coaching and Life-long Monitoring in Cardiovascular Disease in Norrbotten
A study testing Health Coaching and Life-long Monitoring in people with Diabetes and Heart Disease, run by Luleå Tekniska Universitet at 1 site in Sweden.
Trial summary
The purpose of this study is to evaluate whether the introduction of large-scale personalized and technology supported telemonitoring and health coaching interventions produces benefits in terms of health related quality of life, health status and empowerment of patients with a cardiovascular disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Heart Disease, Quality of Life
- What is being tested?
- Health Coaching and Life-long Monitoring
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 741 participants
- Where
- 1 siteSweden
- Study dates
- Mar 2011to Sep 2011
- 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
- Diagnosis of arterial hypertension ischemic heart disease,
- atrial fibrillation or other arrhythmia,
- congestive heart failure (study heart disease)
- HbA1C > 53mmol/mol (study diabetes)
- Age > 18 years
- Capability of filling in questionnaires in the own language
- Capability to use the devices provided
- Being cognitively able to participate
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate whether the introduction of large-scale personalized and technology supported telemonitoring and health coaching interventions produces benefits in terms of health related quality of life, health status and empowerment of patients with a cardiovascular disease. In addition, the trials evaluate the economical and organizational impact of the new services and examine their acceptability by patients and health professionals.
- Conditions
- Diabetes, Heart Disease, Quality of Life
- Being tested
- Health Coaching and Life-long Monitoring
- Keywords
- Promotion health
- Medical subject headings
- Diabetes Mellitus, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health Coaching and Life-long MonitoringProcedure or surgery
Participants receive tablet PCs with software that collects and transmit diagnostic measurements. Measurements are performed by the participants following indications of the health coaching team. Equipment used by all participants: • blood pressure meter, • pedometer • pulse watch• 2-channel electrocardiograph. Measured values are entered manually by the participants, unrealistic values are refused and values are provided with a time-stamp. Measurements is reviewed in a graphical display. Measured values are accessed by the health coaching team that develops an individualized measurement and medication scheme. Reminders are provided by the software and can be exported to personal calendars or mobile phones. Secure authentication of users is be provided
| Study group | Role | What they receive |
|---|---|---|
| Standard care | No intervention | Not described |
| Health coaching and and Life-long Monitoring | Experimental | Not described Receives: Procedure: Health Coaching and Life-long Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
SF-36
Questionnaire, 36 questions ref Ware, 2000 version 2
Measured: 12 months follow-up
Secondary outcomes (8)
HbA1c (for patients with type-2D) Blood pressure for patient with heart disease
HbA1c is a long-term sugar / serum glucose test, it is a blood test that gives a measure of blood sugar levels two to three months before sampling.
Measured: 12 months follow-up
Bloodpressure
Measured: 12 months follow-up
Blood lipids
Measured: 12 months follow-up
Bodyweight
Measured: 12 months follow-up
Smoking habits
Measured: 12 months follow-up
Alcohol consumption
Measured: 12 months follow-up
SOC-13
SOC-13 (sense of coherence, SOC) is a term that reflects the ability to cope with stress and is the essence of the salutogenic theory of health. SOC consists of three subordinate concepts, manageability, meaningfulness and comprehensibility.
Measured: 12 months follow-up
EQ-5D
EQ5D (5d) is a standardized instrument to measure and describe health outcomes. It can be used to measure health at the individual level in clinical settings and to measure a population's health locally and nationally.
Measured: 12 monts follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2011 (estimated)
- Study startMar 2011
- Primary completionAug 2011
- Study completionSep 2011
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 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 741 participants (actual)
Sponsor and investigators
- Lead sponsor
- Luleå Tekniska Universitet
- Sponsor type
- University, hospital or other
- Collaborators
- County Council of Norrbotten, Sweden
- Responsible party
- Principal investigator, Inger Lindberg, Luleå Tekniska Universitet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01478672
- Sponsor's protocol ID
- LTU-Medium health coaching
- Status last verified
- Nov 2011
- First submitted
- 2 Nov 2011
- Last updated
- 23 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lindberg I, Torbjornsen A, Soderberg S, Ribu L. Telemonitoring and Health Counseling for Self-Management Support of Patients With Type 2 Diabetes: A Randomized Controlled Trial. JMIR Diabetes. 2017 Jun 26;2(1):e10. doi: 10.2196/diabetes.6884.
PubMed 30291058
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medium Term Health Coaching and Life-long Monitoring in Cardiovascular Disease in Norrbotten
- ClinicalTrials.gov ID
- NCT01478672
- Acronym / sponsor ID
- LTU-Medium health coaching
- Conditions
- Diabetes, Heart Disease, Quality of Life
- Keywords
- Promotion health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 741 participants (actual)
- Lead sponsor
- Luleå Tekniska UniversitetUniversity, hospital or other
- Collaborators
- County Council of Norrbotten, Sweden
- Study start
- Mar 2011
- Primary completion
- Aug 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 23 Nov 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 study is to evaluate whether the introduction of large-scale personalized and technology supported telemonitoring and health coaching interventions produces benefits in terms of health related quality of life, health status and empowerment of patients with a cardiovascular disease. In addition, the trials evaluate the economical and organizational impact of the new services and examine their acceptability by patients and health professionals.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard care | No intervention | – |
| Health coaching and and Life-long Monitoring | Experimental | Procedure: Health Coaching and Life-long Monitoring |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosis of arterial hypertension ischemic heart disease,
- atrial fibrillation or other arrhythmia,
- congestive heart failure (study heart disease)
- HbA1C > 53mmol/mol (study diabetes)
- Age > 18 years
Key exclusion criteria (0 listed)
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 Coaching and Life-long MonitoringParticipants receive tablet PCs with software that collects and transmit diagnostic measurements. Measurements are performed by the participants following indications of the health coaching team. Equipment used by all participants: • blood pressure meter, • pedometer • pulse watch• 2-channel electrocardiograph. Measured values are entered manually by the participants, unrealistic values are refused and values are provided with a time-stamp. Measurements is reviewed in a graphical display. Measured values are accessed by the health coaching team that develops an individualized measurement and medication scheme. Reminders are provided by the software and can be exported to personal calendars or mobile phones. Secure authentication of users is be provided | Procedure or surgery | Health coaching and and Life-long Monitoring |
Primary outcome
SF-36
Time frame: 12 months follow-up
Questionnaire, 36 questions ref Ware, 2000 version 2
8 secondary outcomes
HbA1c (for patients with type-2D) Blood pressure for patient with heart disease
Time frame: 12 months follow-up
Bloodpressure
Time frame: 12 months follow-up
Blood lipids
Time frame: 12 months follow-up
Bodyweight
Time frame: 12 months follow-up
Smoking habits
Time frame: 12 months follow-up
Alcohol consumption
Time frame: 12 months follow-up
SOC-13
Time frame: 12 months follow-up
EQ-5D
Time frame: 12 monts follow-up
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 23 Nov 2011.
- Derived from this study: PubMed 30291058Lindberg I, Torbjornsen A, Soderberg S, Ribu L. Telemonitoring and Health Counseling for Self-Management Support of Patients With Type 2 Diabetes: A Randomized Controlled Trial. JMIR Diabetes. 2017 Jun 26;2(1):e10. doi: 10.2196/diabetes.6884.
- RENEWING HEALTH, REgioNs of Europe WorkINg toGether for HEALTH Click here for more information about this study:"Link provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Life-long Monitoring in people with Diabetes and Heart Disease, run by Luleå Tekniska Universitet at 1 site in Sweden.
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 8 inclusion and 0 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 23 Nov 2011. 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 Sweden. 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?
SF-36 (time frame: 12 months follow-up). 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 NCT01478672, 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 23 Nov 2011.