Diabetes Type 2I-careNCT01297049
I-care: Stimulating Self-management in Patients With Type 2-diabetes
A study testing Cognitive behavior therapy (CBT) in people with Diabetes Type 2 and Obesity, run by Oslo Metropolitan University at 1 site in Norway.
Trial summary
The overall objective of this pilot study is to develop a cost-effective treatment methodology delivered outside of traditional clinical setting, and based on modern technology for patients with diabetes type 2 also suffering from obesity. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetes Type 2, Obesity
- What is being tested?
- Cognitive behavior therapy (CBT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteNorway
- Study dates
- Apr 2010to Dec 2015
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18-70 years old
- T2DM diagnosed > 3 months prior to study
- HbA1c 7,5-10%
- capability of filling in Norwegian questionnaires
- BMI ≥ 25
- able and willing to give signed informed consent
- willing to attend the full treatment schedule including ability to use mobile phones, computers and pocket computers
Who cannot join
- change in weight > 5kg during the last 3 months
- any mental or physical condition interfering with the protocol
- not having easy access to computers
- having reading problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: I-care: Stimulating Self-management in Patients With Type 2-diabetes Through Web-based Situational Feedback. A Pilot Study.
The overall objective of this pilot study is to develop a cost-effective treatment methodology delivered outside of traditional clinical setting, and based on modern technology for patients with diabetes type 2 also suffering from obesity. This study will investigate the feasibility of web based counselling and situational feedback through mobile supervising. The intention is to treat 10-15 patients. All participants will receive standard treatment delivered by their general practitioners. In addition the participants will fill in and send diaries to the supervisors each evening for 4 weeks reduced to a weekly frequency for the next two months period. The diary's schedule will be an evaluation of the day activities related to meals and food, medication management as well as the performed physical activities. The diary's schedule will also include blood glucose sample, and plans for the next day especially regarding physical activity. The participants will be able to view their own registrations on a web page. Daily/weekly situational feedback will be given to the participants within a cognitive behavioural framework to stimulate self-management. The primary outcome will be the HbA1c levels. Secondary outcomes will include evaluation of lifestyle outcomes such as physical activity levels and eating behaviour, and skills such as self-management of medication. In addition, the interventions effectiveness will examine mental health outcomes such as emotional distress and health-related quality of life.
Read the detailed description
Diabetes and overweight have become a world health epidemic. The number of people suffering of these diseases is increasing due to population growth, aging, urbanization, and increasing prevalence of obesity and physical inactivity. The costs of diabetes affect health services, national productivity as well as individuals and families. Hospital in-patient costs for the treatment of complications are the largest single contributor to direct healthcare costs. Many of these complications and, therefore, their costs, are preventable. Intensive therapy, directed at the control of blood glucose, blood pressure etc, has been shown to be cost-effective in that, although initial costs are increased, it decreases longer term costs as a result of delayed or prevented complications . Diabetes self-management education is a multi-faceted process involving much more than helping people with diabetes to monitor their blood glucose, or take their medication as prescribed. Diabetes education must be an ongoing process rather than a one-time event because a person's health status and need for support change over time.
- Conditions
- Diabetes Type 2, Obesity
- Being tested
- Cognitive behavior therapy (CBT)
- Keywords
- Diabetes, obesity, behavior therapy, self management
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavior therapy (CBT)Behavioural
Also called Life style counselling, Internet based counselling, Situational feedback
All patients will receive standard care (reassurance, education, physiotherapy, and necessary medication). Complementary to this standard care, the participants will be required to closely monitor their blood glucose levels, weight, eating behavior and daily activities, and to relay this information to the nurse specialist trained in treating somatic patients with CBT. The nurse will then suggest appropriate treatment decisions, the patients will receive situational feedback based on the electronic diary during 3 months (daily during 4 weeks intensive treatment and weekly during 2 months as a complement).
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle counseling | Experimental | Not described Receives: Behavioral: Cognitive behavior therapy (CBT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood glucose control with changes in Glycated hemoglobin (HbA1c) values
HBA1c is a form of hemoglobin used primarily to identify the average plasma glucose concentration over prolonged periods of time. It is formed in a non-enzymatic glycation pathway by hemoglobin's exposure to plasma glucose. Normal levels of glucose produce a normal amount of glycated hemoglobin. As the average amount of plasma glucose increases, the fraction of glycated hemoglobin increases in a predictable way. This serves as a marker for average blood glucose levels over the previous months prior to the measurement
Measured: At the baseline and at the end of the intervention (3 months)
Secondary outcomes (4)
Health Education Impact Questionnaire (heiQ);
heiQ is a user-friendly instrument for the comprehensive evaluation of patient education programs with the following dimensions: positive and active engagement in life, health directed behavior, skill and technique acquisition, constructive attitudes and approaches, self-monitoring and insight, health service navigation, social integration and support, and emotional well-being.
Measured: At the baseline and after the end of the intervention (3 months)
Problem Areas in Diabetes (PAID)
PAID is a brief self-report measure of diabetes-related distress that has been found to be useful in patients with diabetes (both type1 and 2). PAID scores have been found to show positive associations with HbA1c, and are a major predictor of poor adherence to treatment not involving general emotional distress
Measured: At the baseline and after the end of the intervention (3 months)
Food frequency questionnaire FFQ
FFQ is a measure designed to measure average long-term diet or usual consumption with specified food items.
Measured: At the baseline and after the end of the intervention (3 months)
Audit of Diabetes Dependence Quality of Life (ADDQoL-19)
ADDQoL19 is a health-related quality of life questionnaire well designed to assess to what extent diabetes may affect different aspects of health related quality of life. The ADDQoL includes 2 introductory questions and 18 specific items, with the purpose of assessing, according to the patient's perspective, how much better his or her life would be if he/she did not have diabetes and how important each of these 19 aspects of life are for the individual.
Measured: At the baseline and after the end of the intervention (3months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2011 (estimated)
- Study startApr 2010
- Primary completionJul 2015
- Study completionDec 2015
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 Diabetes 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo Metropolitan University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo
- Responsible party
- Sponsor
- Investigators
- Andréa AG Nes, Mc, Principal investigator, Oslo College UniversityHilde Eide, Professor, Principal investigator, Oslo College University/Buskerud College University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01297049
- Sponsor's protocol ID
- 2010/427b
- Acronym
- I-care
- Status last verified
- Sep 2018
- First submitted
- 15 Feb 2011
- Last updated
- 24 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Nes AAG, van Dulmen S, Brembo EA, Eide H. An mHealth Intervention for Persons with Diabetes Type 2 Based on Acceptance and Commitment Therapy Principles: Examining Treatment Fidelity. JMIR Mhealth Uhealth. 2018 Jul 3;6(7):e151. doi: 10.2196/mhealth.9942.
PubMed 29970357
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- I-care: Stimulating Self-management in Patients With Type 2-diabetes Through Web-based Situational Feedback. A Pilot Study.
- ClinicalTrials.gov ID
- NCT01297049
- Acronym / sponsor ID
- I-care / 2010/427b
- Conditions
- Diabetes Type 2, Obesity
- Keywords
- Diabetes, obesity, behavior therapy, self management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Oslo Metropolitan UniversityUniversity, hospital or other
- Collaborators
- University of Oslo
- Study start
- Apr 2010
- Primary completion
- Jul 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 16 Feb 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 overall objective of this pilot study is to develop a cost-effective treatment methodology delivered outside of traditional clinical setting, and based on modern technology for patients with diabetes type 2 also suffering from obesity. This study will investigate the feasibility of web based counselling and situational feedback through mobile supervising. The intention is to treat 10-15 patients. All participants will receive standard treatment delivered by their general practitioners. In addition the participants will fill in and send diaries to the supervisors each evening for 4 weeks reduced to a weekly frequency for the next two months period. The diary's schedule will be an evaluation of the day activities related to meals and food, medication management as well as the performed physical activities. The diary's schedule will also include blood glucose sample, and plans for the next day especially regarding physical activity. The participants will be able to view their own registrations on a web page. Daily/weekly situational feedback will be given to the participants within a cognitive behavioural framework to stimulate self-management. The primary outcome will be the HbA1c levels. Secondary outcomes will include evaluation of lifestyle outcomes such as physical activity levels and eating behaviour, and skills such as self-management of medication. In addition, the interventions effectiveness will examine mental health outcomes such as emotional distress and health-related quality of life.
Detailed description
Diabetes and overweight have become a world health epidemic. The number of people suffering of these diseases is increasing due to population growth, aging, urbanization, and increasing prevalence of obesity and physical inactivity. The costs of diabetes affect health services, national productivity as well as individuals and families. Hospital in-patient costs for the treatment of complications are the largest single contributor to direct healthcare costs. Many of these complications and, therefore, their costs, are preventable. Intensive therapy, directed at the control of blood glucose, blood pressure etc, has been shown to be cost-effective in that, although initial costs are increased, it decreases longer term costs as a result of delayed or prevented complications . Diabetes self-management education is a multi-faceted process involving much more than helping people with diabetes to monitor their blood glucose, or take their medication as prescribed. Diabetes education must be an ongoing process rather than a one-time event because a person's health status and need for support change over time.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lifestyle counseling | Experimental | Behavioral: Cognitive behavior therapy (CBT) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- age 18-70 years old
- T2DM diagnosed > 3 months prior to study
- HbA1c 7,5-10%
- capability of filling in Norwegian questionnaires
- BMI ≥ 25
Key exclusion criteria (4 listed)
- change in weight > 5kg during the last 3 months
- any mental or physical condition interfering with the protocol
- not having easy access to computers
- having reading problems
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 |
|---|---|---|
| Cognitive behavior therapy (CBT)Also: Life style counselling, Internet based counselling, Situational feedbackAll patients will receive standard care (reassurance, education, physiotherapy, and necessary medication). Complementary to this standard care, the participants will be required to closely monitor their blood glucose levels, weight, eating behavior and daily activities, and to relay this information to the nurse specialist trained in treating somatic patients with CBT. The nurse will then suggest appropriate treatment decisions, the patients will receive situational feedback based on the electronic diary during 3 months (daily during 4 weeks intensive treatment and weekly during 2 months as a complement). | Behavioural | Lifestyle counseling |
Primary outcome
Blood glucose control with changes in Glycated hemoglobin (HbA1c) values
Time frame: At the baseline and at the end of the intervention (3 months)
HBA1c is a form of hemoglobin used primarily to identify the average plasma glucose concentration over prolonged periods of time. It is formed in a non-enzymatic glycation pathway by hemoglobin's exposure to plasma glucose. Normal levels of glucose produce a normal amount of glycated hemoglobin. As the average amount of plasma glucose increases, the fraction of glycated hemoglobin increases in a predictable way. This serves as a marker for average blood glucose levels over the previous months prior to the measurement
4 secondary outcomes
Health Education Impact Questionnaire (heiQ);
Time frame: At the baseline and after the end of the intervention (3 months)
Problem Areas in Diabetes (PAID)
Time frame: At the baseline and after the end of the intervention (3 months)
Food frequency questionnaire FFQ
Time frame: At the baseline and after the end of the intervention (3 months)
Audit of Diabetes Dependence Quality of Life (ADDQoL-19)
Time frame: At the baseline and after the end of the intervention (3months)
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 24 Sep 2018.
- Derived from this study: PubMed 29970357Nes AAG, van Dulmen S, Brembo EA, Eide H. An mHealth Intervention for Persons with Diabetes Type 2 Based on Acceptance and Commitment Therapy Principles: Examining Treatment Fidelity. JMIR Mhealth Uhealth. 2018 Jul 3;6(7):e151. doi: 10.2196/mhealth.9942.
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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.
Andréa AG Nes, Mc principal investigator
Oslo College University
Hilde Eide, Professor principal investigator
Oslo College University/Buskerud College University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive behavior therapy (CBT) in people with Diabetes Type 2 and Obesity, run by Oslo Metropolitan University at 1 site in Norway.
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 7 inclusion and 4 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 24 Sep 2018. 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 Norway. 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?
Blood glucose control with changes in Glycated hemoglobin (HbA1c) values (time frame: At the baseline and at the end of the intervention (3 months)). 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 NCT01297049, 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 24 Sep 2018.