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I-care: Stimulating Self-management in Patients With Type 2-diabetes (I-care)

Primary Purpose

Diabetes Type 2, Obesity

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Cognitive behavior therapy (CBT)
Sponsored by
Oslo Metropolitan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diabetes Type 2 focused on measuring Diabetes, obesity, behavior therapy, self management

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Oslo College University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lifestyle counseling

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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
Food frequency questionnaire FFQ
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)
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.

Full Information

First Posted
February 15, 2011
Last Updated
September 21, 2018
Sponsor
Oslo Metropolitan University
Collaborators
University of Oslo
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1. Study Identification

Unique Protocol Identification Number
NCT01297049
Brief Title
I-care: Stimulating Self-management in Patients With Type 2-diabetes
Acronym
I-care
Official Title
I-care: Stimulating Self-management in Patients With Type 2-diabetes Through Web-based Situational Feedback. A Pilot Study.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oslo Metropolitan University
Collaborators
University of Oslo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Type 2, Obesity
Keywords
Diabetes, obesity, behavior therapy, self management

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lifestyle counseling
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Cognitive behavior therapy (CBT)
Other Intervention Name(s)
Life style counselling, Internet based counselling, Situational feedback
Intervention Description
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).
Primary Outcome Measure Information:
Title
Blood glucose control with changes in Glycated hemoglobin (HbA1c) values
Description
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
Time Frame
At the baseline and at the end of the intervention (3 months)
Secondary Outcome Measure Information:
Title
Health Education Impact Questionnaire (heiQ);
Description
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.
Time Frame
At the baseline and after the end of the intervention (3 months)
Title
Problem Areas in Diabetes (PAID)
Description
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
Time Frame
At the baseline and after the end of the intervention (3 months)
Title
Food frequency questionnaire FFQ
Description
FFQ is a measure designed to measure average long-term diet or usual consumption with specified food items.
Time Frame
At the baseline and after the end of the intervention (3 months)
Title
Audit of Diabetes Dependence Quality of Life (ADDQoL-19)
Description
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.
Time Frame
At the baseline and after the end of the intervention (3months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andréa AG Nes, Mc
Organizational Affiliation
Oslo College University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hilde Eide, Professor
Organizational Affiliation
Oslo College University/Buskerud College University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oslo College University
City
Oslo
State/Province
Arkeshus
ZIP/Postal Code
0130
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
29970357
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.
Results Reference
derived

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I-care: Stimulating Self-management in Patients With Type 2-diabetes

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