Clinical trial NCT02637154: Motivational Interview in Adolescents With Poorly Controlled Type 1 Diabetes
Official title: The Effect of Motivational Interview and Intensive Education on HbA1C Values and Glucose Variability in Adolescents With Poorly Controlled Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Keywords: Adolescent
Type 1 diabetes
Metabolic control
Motivational interviewing
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2015-12-22
Enrollment: 50
Sex: ALL
Minimum age (years): 12
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change in HbA1C values (mmol/mol)
timeFrame: 12 months
measure: Change in glycaemic variability
timeFrame: 12 months
Secondary outcomes:
measure: Influence of changes in markers of vascular health (IMT)
timeFrame: 12 months
measure: Influence of changes in markers of vascular health (PWV)
timeFrame: 12 months
measure: Influence of changes in bone mineral density (BMD)
timeFrame: 12 months
measure: Influence of changes in quality of life
timeFrame: 12 months
measure: Influence of changes in markers of inflammation (IL-6 - pg/ml)
timeFrame: 12 months
measure: Influence of changes in markers of inflammation (high-sensitive-c-reactive-protein CRP - mg/l).
timeFrame: 12 months
measure: Influence of changes in insulin-like-growth-factor IGF-I levels
timeFrame: 12 months
measure: Influence of changes in markers of bone turnover (serum aminoterminal propeptide of type I collagen (PINP - ng/ml)).
timeFrame: 12 months
measure: Influence of changes in vitamin D status (25-hydroxy-D) ng/ml
timeFrame: 12 months
measure: Influence of changes in marker of bone turnover: osteocalcin (ng/ml)
timeFrame: 12 months
measure: Influence of changes in marker of bone turnover: aminoterminal telopeptide of type I collagen (INTP - ng/ml)
timeFrame: 12 months
Other outcomes:
Locations:
city: Espoo
country: Finland
facility: Helsinki University Central Hospital, Pediatric Diabetes Unit Espoo
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital, Pediatric Endocrinology Unit
city: Oulu
country: Finland
facility: Oulu University Hospital, Pediatric Endocrinology Unit
Study officials:
affiliation: Specialist in Pediatric Endocrinology
name: Mari Pulkkinen, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: White NH, Cleary PA, Dahms W, Goldstein D, Malone J, Tamborlane WV; Diabetes Control and Complications Trial (DCCT)/Epidemiology of Diabetes Interventions and Complications (EDIC) Research Group. Beneficial effects of intensive therapy of diabetes during adolescence: outcomes after the conclusion of the Diabetes Control and Complications Trial (DCCT). J Pediatr. 2001 Dec;139(6):804-12. doi: 10.1067/mpd.2001.118887.
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citation: Valerio G, del Puente A, Esposito-del Puente A, Buono P, Mozzillo E, Franzese A. The lumbar bone mineral density is affected by long-term poor metabolic control in adolescents with type 1 diabetes mellitus. Horm Res. 2002;58(6):266-72. doi: 10.1159/000066441.
citation: Sarkola T, Redington A, Keeley F, Bradley T, Jaeggi E. Transcutaneous very-high-resolution ultrasound to quantify arterial wall layers of muscular and elastic arteries: validation of a method. Atherosclerosis. 2010 Oct;212(2):516-23. doi: 10.1016/j.atherosclerosis.2010.06.043. Epub 2010 Jul 7.
citation: Pulkkinen MA, Tuomaala AK, Hero M, Gordin D, Sarkola T. Motivational Interview to improve vascular health in Adolescents with poorly controlled type 1 Diabetes (MIAD): a randomized controlled trial. BMJ Open Diabetes Res Care. 2020 Jul;8(1):e001216. doi: 10.1136/bmjdrc-2020-001216.