Clinical trial NCT01297049: I-care: Stimulating Self-management in Patients With Type 2-diabetes
Official title: I-care: Stimulating Self-management in Patients With Type 2-diabetes Through Web-based Situational Feedback. A Pilot Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Type 2
Obesity
Keywords: Diabetes
obesity
behavior therapy
self management
Lead sponsor: Oslo Metropolitan University
Sponsor class: OTHER
Collaborators: name: University of Oslo
First posted: 2011-02-16
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Blood glucose control with changes in Glycated hemoglobin (HbA1c) values
timeFrame: At the baseline and at the end of the intervention (3 months)
Secondary outcomes:
measure: Health Education Impact Questionnaire (heiQ);
timeFrame: At the baseline and after the end of the intervention (3 months)
measure: Problem Areas in Diabetes (PAID)
timeFrame: At the baseline and after the end of the intervention (3 months)
measure: Food frequency questionnaire FFQ
timeFrame: At the baseline and after the end of the intervention (3 months)
measure: Audit of Diabetes Dependence Quality of Life (ADDQoL-19)
timeFrame: At the baseline and after the end of the intervention (3months)
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo College University
state: Arkeshus
Study officials:
affiliation: Oslo College University
name: Andréa AG Nes, Mc
role: PRINCIPAL_INVESTIGATOR
affiliation: Oslo College University/Buskerud College University
name: Hilde Eide, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.