Motivational Interview in Adolescents With Poorly Controlled Type 1 Diabetes

Study Overview
=================
Brief Summary
-----------------
This study investigates the effect of motivational interviewing and intensive education on HbA1c values and glucose variability in poorly controlled adolescent T1D patients. In the present study motivational interviewing (MI) will be integrated to clinicians' daily practice, as a part of normal clinical visit. In this randomized, controlled trial hypothesis is, that applying motivational interviewing during regular clinical visits results in better acceptance and subsequently enhanced metabolic control in adolescents with poorly controlled type 1 diabetes.

Detailed Description
-----------------
Background Type 1 diabetes (T1D) patients with optimal glycemic control suffer markedly less from long term diabetic complications than those with poor control. Increased glycohemoglobin (HbA1C) levels predict the complication risk. The development of diabetic complications seems to accelerate during puberty, and poor metabolic control during adolescence or young adulthood markedly increases the incidence of micro- or macrovascular complications during subsequent years. On the other hand, intensive treatment during adolescence has been reported to reduce the risk of microvascular complications, even if the control later on becomes poorer. This implicates that interventions targeting at improved glycemic control during adolescence probably have sustained beneficial effects on the overall morbidity in patients T1D. The glycemic control of Finnish adolescents with T1D is poor. Insulin resistance and impaired metabolic control are common problems. Treatment of the disease during puberty can be complicated and particularly treatment adherence often declines in youth. Inexpensive and easily adoptable methods for clinicians are needed to overcome treatment problems faced with adolescent patients. At present, there are no generally recommended approaches for clinicians to apply in order to motivate adolescents with poor glycemic control towards better treatment adherence. To this end, motivational interviewing (MI) has been used to an increasing degree in health care professionals in the treatment of variety of disorders and behavioral problems, such as alcohol and drug problems, gambling, and cardiovascular diseases. Motivational interviewing is a counseling approach designed to facilitate intrinsic motivation in the patient to change behavior. Significant body of evidence supports the view that MI improves commitment to care when added to other treatment. However, only a few studies have evaluated MI in the treatment of adolescent diabetes patients, with outcomes ranging from substantial benefit to neutral. MI is a promising approach for the treatment adolescent type 1 diabetics but there is a clear demand for methodologically solid studies. Aims The aim of the present study is to investigate the effect of motivational interviewing and intensive education on HbA1c values and glucose variability in poorly controlled adolescent T1D patients. Secondarily, it will be investigated whether improved glycemic control is associated with improvements in vascular parameters, metabolic markers, markers of bone health and health related quality of life. Hypothesis In the present study motivational interviewing (MI) will be integrated to clinicians' daily practice, as a part of normal clinical visit. In this randomized, controlled trial hypothesis is, that applying motivational interviewing during regular clinical visits results in better acceptance and subsequently enhanced metabolic control in adolescents with poorly controlled type 1 diabetes. Study protocol All physicians participating in the study are trained to use standardized educational (SE) material. In addition half of the physicians are randomized to motivational interview (MI) group. They are trained by professor Martti Tuomisto's group to use MI in a one day workshop with refresher practical rehearsal course prior to study start. To secure that MI is sufficiently applied, the physician/patient discussions will be monitored by the Tuomisto group. All researchers randomized to the MI group will receive continuous feedback from the Tuomisto group on their performance (i.e. level of applying MI) and if needed re-trained for MI. Patients with Hba1c > 75 mmol/mol are identified from hospital records, and are considered eligible for the current study. The patients willing to participate are randomized either to MI plus SE or SE group. Study Protocol Every visit includes a physical examination (including evaluation of the stage of puberty and testis volume at the start and at 12 months), measurement of height, weight, growth velocity, body mass index (BMI), blood pressure and waist circumference, usage of SE material, and in the MI group usage of MI during the patient visit. The intervention in the MI group consists of a MI type of introduction at the beginning of each patient visit, and applying MI principles and procedures on each educational item discussed during the patient visit. Adherence to MI intervention protocols will be checked using recorded samples of therapy interactions. HbA1c levels are also measured in every visit. Six days blinded continuous glucose monitoring will be performed at baseline and during the follow-up (0, 6 and 12 months). Fasting venous blood samples are obtained at baseline and at 12 months. Investigators will evaluate health related quality of life (QoL) in study participants at baseline, and at completion of the study. Dual- energy x-absorptiometry (DXA) is performed at baseline and at 12 months. Vascular assessments will be performed at baseline and at study completion.

Official Title
-----------------
The Effect of Motivational Interview and Intensive Education on HbA1C Values and Glucose Variability in Adolescents With Poorly Controlled Type 1 Diabetes

Conditions
-----------------
Diabetes Mellitus, Type 1

Intervention / Treatment
-----------------
* Behavioral: Motivational Interviewing
* Behavioral: Standard Education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: the diagnosis of type 1 diabetes with at least 2 years duration and HbA1c > 75 mmol/mol on two consecutive visits, age 12-15.9 years and pubertal (Tanner) stage 2 or more at inclusion Exclusion Criteria: celiac disease with poor control; diagnosis of psychiatric disease; and other chronic disease requiring per oral glucocorticoid treatment

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 16 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Motivational Interviewing<br>With 30 patients Motivational Interviewing method will be used during each visit | Behavioral: Motivational Interviewing<br>* Motivational Interviewing method<br>|
| Active Comparator: Standard Education<br>With 30 patients Standard Education material will be used during each visit | Behavioral: Standard Education<br>* Standard Education material will be used<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1C values (mmol/mol) | HbA1c levels (mmol/mol) are measured in every visit (AfinionTM). | 12 months | 
| Change in glycaemic variability | Six days blinded continuous glucose monitoring (CGM) (iPro, Medtronic) will be performed at baseline and during the follow-up. Blinded CGM curves (0 and 12mo) will be analyzed to study effect on glycemic variability. Standard deviation (SD) of blood glucose values and mean amplitude of glycemic excursions (MAGE) will be used as parameters to define glycemic variability. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Influence of changes in markers of vascular health (IMT) | The association between glycemic control and vascular wall morphology is assessed by imaging of the carotid, femoral, brachial and radial artery intima media thickness (IMT as millimeters - mm:s) with ultrasound. Results will be compared to previously established measurements from healthy children. Vascular assessment will be performed at baseline and at study completion. | 12 months | 
| Influence of changes in markers of vascular health (PWV) | The association between glycemic control and central and peripheral arterial thickness is assessed with pulse wave velocity (PWV - as meters / second - m/s) using applanation tonometry. Results will be compared to previously established measurements from healthy children. Vascular assessments will be performed at baseline and at study completion. | 12 months | 
| Influence of changes in bone mineral density (BMD) | Dual- energy x-absorptiometry (DXA) is performed at baseline and at 12 months for analyses of BMD (total body less head, lumbar spine) and body composition, using the Hologic Discovery device (indicated as SD of Z-score). | 12 months | 
| Influence of changes in quality of life | Health related quality of life (QoL) in study participants will be evaluated at baseline, and at completion of the study with the KINDL-R questionnaires | 12 months | 
| Influence of changes in markers of inflammation (IL-6 - pg/ml) | Fasting venous blood samples are obtained at baseline and at 12 months for later analysis of serum inflammatory marker serum IL-6. | 12 months | 
| Influence of changes in markers of inflammation (high-sensitive-c-reactive-protein CRP - mg/l). | Fasting venous blood samples are obtained at baseline and at 12 months for later analysis of serum inflammatory marker hs-CRP. | 12 months | 
| Influence of changes in insulin-like-growth-factor IGF-I levels | Fasting venous blood samples are obtained at baseline and at 12 months for later analysis of serum insulin-like-growth-factor IGF-I (ng/ml) levels. | 12 months | 
| Influence of changes in markers of bone turnover (serum aminoterminal propeptide of type I collagen (PINP - ng/ml)). | Fasting venous blood samples are obtained at baseline and at 12 months for later analysis of markers of bone turnover (PINP - ng/ml). | 12 months | 
| Influence of changes in vitamin D status (25-hydroxy-D) ng/ml | Fasting venous blood samples are obtained at baseline and at 12 months for analysis of changes in vitamin D status. | 12 months | 
| Influence of changes in marker of bone turnover: osteocalcin (ng/ml) | Fasting venous blood samples are obtained at baseline and at 12 months for analysis of changes in bone turnover marker osteocalcin. | 12 months | 
| Influence of changes in marker of bone turnover: aminoterminal telopeptide of type I collagen (INTP - ng/ml) | Fasting venous blood samples are obtained at baseline and at 12 months for analysis of changes in bone turnover marker INTP. | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adolescent, Type 1 diabetes, Metabolic control, Motivational interviewing