Clinical trial NCT03753997: A Trial of Diabetes-educated Psychologist to Improve HbA1c and Reduce Diabetes-related Distress
Official title: A Randomized Trial of Diabetes-educated Psychologist to Improve HbA1c and Reduce Diabetes-related Distress
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Type1diabetes
Psychology Functional Behavior
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
First posted: 2018-11-27
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Type 1 diabetes is associated with a significant increase in mortality, cardiovascular disease, injuries on eyes and kidneys. These risks are largely dependent on glycemic control. Multiple strategies of achieving good glycemic control exist. Despite this, only about 20 % of patients in Sweden reach the target HbA1c of ≤ 52 mmol/mol.

It is well-known that when the motivation is high, a large proportion of patients reach good glycaemic control with current treatments, e.g. most pregnant women reach a much better glycaemic control. The patient is then motivated to a greater extent in managing the disease, e.g. by carefully dosing insulin and more closely monitoring blood glucose levels.

Moreover, besides lack of motivation, specific psychiatric conditions are well-known barriers in being compliant with treatments such as depression, eating disorders and attention deficit disorders (ADHD). Further, identified specific diabetes-related psychosocial factors include severe fear of hypoglycaemia, diabetes-burnout, unrealistic treatment goals, poor relationship with physician, feelings of powerlessness and treatment skepticism. These parameters can be measured via a diabetes distress scale where a high score is correlated to higher HbA1c.

The majority of outpatient diabetes clinics in Sweden today request the resource of a diabetes-educated psychologist. However, more evidence is needed from randomized multicentre trials whether such a resource would help to improve HbA1c, reduce diabetes-related distress and improve quality of life.

The primary aim of the current study is to evaluate whether the assistance of a diabetes-educated psychologist in the diabetes care of patients with type 1 diabetes improves HbA1c. Secondary endpoints include studying its influence on diabetes-related distress and quality of life. The study is a 1 year randomized trial where the intervention group will meet with a diabetes-educated psychologist in addition to conventional care.


Eligibility criteria: Inclusion Criteria:

* Informed consent obtained before trial-related activities (i.e., any activity that would not have been performed during routine patient management)
* Clinical diagnosis of Type 1 diabetes
* Adult patients over 18 years of age
* HbA1c \> 62 mmol/mol

Exclusion Criteria:

* Type 2 diabetes
* Diabetes duration \<1 year
* Long-term Systemic glucocorticoid treatment during the last 3 months
* Changed treatment the last 3 months regarding MDI vs. Insulin pump or added or stopped CGM or FGM therapy
* Current or planned pregnancy or breastfeeding during the next 12 months
* Planned move during the next 12 months making it not possible to participate in study activities
* Other reason determined by the investigator not being appropriate for participation

Primary outcomes:
measure: Change in HbA1c from baseline to 52 weeks follow-up
timeFrame: 52 weeks
Secondary outcomes:
measure: Change in Diabetes distress scale score from baseline to week 52
timeFrame: 52 weeks
measure: Change in quality of life score (ADDQoL) from baseline to week 52
timeFrame: 52 weeks
measure: score of Diabetes Treatment satisfaction questionnaire - change (DTSQc) at week 52
timeFrame: 52 weeks
Other outcomes:
measure: Change in the Diabetes Treatment satisfaction questionnaire - status (DTSQs) score from baseline to week 52
timeFrame: 52 weeks
measure: Change in the score of the hypoglycaemia confidence questionnaire from baseline to week 52
timeFrame: 52 weeks
measure: Proportion of patients with HbA1c less than 59 mmol/mol at week 52
timeFrame: 52 weeks
measure: Proportion of patients with HbA1c less than 53 mmol/mol at week 52
timeFrame: 52 weeks
measure: Proportion of patients lowering HbA1c 5 mmol/mol or more from baseline to week 52
timeFrame: 52 weeks
measure: Change in total insulin dose from baseline to week 52
timeFrame: 52 weeks
measure: change weight from baseline to week 52
timeFrame: 52 weeks
measure: Change in systolic and diastolic blood pressure from baseline to week 52
timeFrame: 52 week
Locations:
city: Uddevalla
country: Sweden
facility: NU Hospital Group
Study officials:
affiliation: NU-Hospital Organization, Sweden
name: Marcus Lind, PhD
role: PRINCIPAL_INVESTIGATOR
References: