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

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.

Study Overview

• Status: Recruiting
• Conditions: Type1diabetes; Psychology Functional Behavior
• Intervention / Treatment: Behavioral: Treatment by a diabetes educated psychologist

• Study Type: Interventional
• Enrollment (Anticipated): 142
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marie Ekström, BSc nursing; Phone Number: +46104350000; Email: marie.el.ekstrom@vgregion.se
• Study Contact Backup: Name: Arndís Ólafsdóttir, PgD; Phone Number: +46104350000; Email: finna.olafdottir@vgregion.se

Study Locations

• Sweden
  • Uddevalla, Sweden, 45180
    • Recruiting
    • NU Hospital Group
    • Contact: Marie Ekström; Phone Number: +4673-063 23 72; Email: marie.el.ekstrom@vgregion.se
    • Contact: Arndís F Òlafsdóttir; Phone Number: +46700 82 22 55; Email: finna.olafsdottir@vgregion.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Conventional therapy; Patiens´s will come to the clinic for regular contact with a diabetes nurse.
EXPERIMENTAL: Treatment by a Psychologist; Patients will meet with a diabetes educated psychologist over 9 months and will come to the clinic for regular contact with a diabetes nurse	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in HbA1c from baseline to 52 weeks follow-up	52 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Diabetes distress scale score from baseline to week 52	Diabetes Distress scale is a questionnaire with 28 questions where patients answer on a scale between 1-6.	52 weeks
Change in quality of life score (ADDQoL) from baseline to week 52	ADDQoL (actual name for questionnaire) is a quality of life questionnaire with 19 questions. Answers are on a scale of 1-4,1-5,1-6 and 1-7	52 weeks
score of Diabetes Treatment satisfaction questionnaire - change (DTSQc) at week 52	8 questions which patients answer on a scale of -3 to 3	52 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the Diabetes Treatment satisfaction questionnaire - status (DTSQs) score from baseline to week 52	8 questions which patients answer on a scale of 6 to 0	52 weeks
Change in the score of the hypoglycaemia confidence questionnaire from baseline to week 52	9 questions with 4 answer possibilities. Not confident at all, to very confident	52 weeks
Proportion of patients with HbA1c less than 59 mmol/mol at week 52		52 weeks
Proportion of patients with HbA1c less than 53 mmol/mol at week 52		52 weeks
Proportion of patients lowering HbA1c 5 mmol/mol or more from baseline to week 52		52 weeks
Change in total insulin dose from baseline to week 52		52 weeks
change weight from baseline to week 52		52 weeks
Change in systolic and diastolic blood pressure from baseline to week 52	Change in systolic and diastolic blood pressure.	52 week

Collaborators and Investigators

• Sponsor: Vastra Gotaland Region
• Investigators: Principal Investigator: Marcus Lind, PhD, NU-Hospital Organization, Sweden

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2019
• Primary Completion (ANTICIPATED): June 30, 2024
• Study Completion (ANTICIPATED): December 31, 2026

Study Registration Dates

• First Submitted: November 21, 2018
• First Submitted That Met QC Criteria: November 23, 2018
• First Posted (ACTUAL): November 27, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 3, 2022
• Last Update Submitted That Met QC Criteria: May 2, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: Psychologystudy

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No