NCT03753997

A Trial of Diabetes-educated Psychologist to Improve HbA1c and Reduce Diabetes-related Distress

A Randomized Trial of Diabetes-educated Psychologist to Improve HbA1c and Reduce Diabetes-related Distress

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 142 (estimated)
• Sponsor: Vastra Gotaland Region · Other Government
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type1diabetes
• Psychology Functional Behavior

Interventions

Type	Name	Description
BEHAVIORAL	Treatment by a diabetes educated psychologist	Patients will meet a diabetes educated psychologist. There will be a minimum of 5 meetings during the first 3 months and then in the following 6 months there will be a minimum of 2 meetings. More meetings will be scheduled if needed.

Timeline

• Start date: 2019-01-01
• Primary completion: 2024-12-30
• Completion: 2026-12-31
• First posted: 2018-11-27
• Last updated: 2024-05-30

Locations

1 site across 1 country: Sweden