I-care: Stimulating Self-management in Patients With Type 2-diabetes (I-care)
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|ClinicalTrials.gov Identifier: NCT01297049|
Recruitment Status : Completed
First Posted : February 16, 2011
Last Update Posted : September 24, 2018
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Type 2 Obesity||Behavioral: Cognitive behavior therapy (CBT)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||I-care: Stimulating Self-management in Patients With Type 2-diabetes Through Web-based Situational Feedback. A Pilot Study.|
|Study Start Date :||April 2010|
|Actual Primary Completion Date :||July 2015|
|Actual Study Completion Date :||December 2015|
|Experimental: Lifestyle counseling||
Behavioral: Cognitive behavior therapy (CBT)
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).
- 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
- Health Education Impact Questionnaire (heiQ); [ Time Frame: At the baseline and after the end of the intervention (3 months) ]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.
- Problem Areas in Diabetes (PAID) [ Time Frame: At the baseline and after the end of the intervention (3 months) ]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
- Food frequency questionnaire FFQ [ Time Frame: At the baseline and after the end of the intervention (3 months) ]FFQ is a measure designed to measure average long-term diet or usual consumption with specified food items.
- Audit of Diabetes Dependence Quality of Life (ADDQoL-19) [ Time Frame: At the baseline and after the end of the intervention (3months) ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01297049
|Oslo College University|
|Oslo, Arkeshus, Norway, 0130|
|Principal Investigator:||Andréa AG Nes, Mc||Oslo College University|
|Principal Investigator:||Hilde Eide, Professor||Oslo College University/Buskerud College University|