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

NCT01297049 | Completed DMC

• 1 other identifier: 2010/427b
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Type 2; Obesity

Keywords

Diabetes; obesity; behavior therapy; self management

Outcome Measures

Primary Outcomes (1)

• 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

  At the baseline and at the end of the intervention (3 months)

Secondary Outcomes (4)

• Health Education Impact Questionnaire (heiQ);

  At the baseline and after the end of the intervention (3 months)

• Problem Areas in Diabetes (PAID)

  At the baseline and after the end of the intervention (3 months)

• Food frequency questionnaire FFQ

  At the baseline and after the end of the intervention (3 months)

• Audit of Diabetes Dependence Quality of Life (ADDQoL-19)

  At the baseline and after the end of the intervention (3months)

Study Arms (1)

Lifestyle counseling

EXPERIMENTAL

Behavioral: Cognitive behavior therapy (CBT)

Interventions

Cognitive behavior therapy (CBT) BEHAVIORAL

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).

Also known as: Life style counselling, Internet based counselling, Situational feedback

Lifestyle counseling

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oslo Metropolitan University: lead
• University of Oslo: collaborator

Study Sites (1)

Oslo College University

Oslo, Arkeshus, 0130, Norway

Location

Related Publications (1)

• 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.

  PMID: 29970357 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity; Diabetes Mellitus

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Andréa AG Nes, Mc

  Oslo College University

  PRINCIPAL INVESTIGATOR

• Hilde Eide, Professor

  Oslo College University/Buskerud College University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2011
• First Posted: February 16, 2011
• Study Start: April 1, 2010
• Primary Completion: July 1, 2015
• Study Completion: December 1, 2015
• Last Updated: September 24, 2018

Record last verified: 2018-09

Locations

NO (1)