Clinical trial NCT04797429: Improving Glycaemic Control in Patients With Type 2 Diabetes Mellitus Through Peer Support Instant Messaging
Official title: Improving Glycaemic Control in Patients With Type 2 Diabetes Mellitus Through Peer Support Instant Messaging: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Peer Support
Instant Messaging Service
Keywords: Diabetes Mellitus Type 2
Online Intervention
Peer Support
Instant Messaging Service
Glycaemic Control
Lead sponsor: St. Pölten University of Applied Sciences
Sponsor class: OTHER
Collaborators: name: Karl Landsteiner University of Health Sciences
name: Austrian Health Insurance Fund
First posted: 2021-03-15
Enrollment: 68
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Diabetes mellitus is one of the four priority non-communicable diseases worldwide. Globally, 425 million adults suffered from diabetes mellitus (7.2-11.3%) in 2017 and the International Diabetes Federation estimates an increase of 48% of the prevalence until 2045. Type 2 diabetes, which is the most common type of diabetes, is mainly seen in adults older than 40 years. Diabetes can lead to serious long-term complications as well as a lower quality of life, worse mental health, and a reduced life expectancy. Due to the chronical character of diabetes, the disease requires continuous therapy, regular medical appointments, and good adherence of those suffering. Therefore, diabetes self-management education (DSME) plays a significant role to increase patient's self-management capacity and improve diabetes therapy. Research indicates that these outcomes might be difficult to maintain and seem to decline soon after DSME ends. Consequently, effective strategies to preserve the positive effects of DSME are needed. Preliminary results show that peer support, which means support from a person who has experiential knowledge of a specific behaviour or stressor and similar characteristics as the target population, is associated with better outcomes in terms of HbA1c, cardiovascular disease risk factors or self-efficacy at lower cost compared to standard therapy. Although those results are promising, research on peer support in diabetes care is still in its infancy and the influence of various factors is unclear. Peer support instant messaging services (IMS) approaches have significant potential for diabetes management because support can be provided easily and prompt, is inexpensive, and needs less effort to attend compared to standard therapy. Furthermore, almost half of the 40-69-year-old age group, which is mostly affected by the onset of type 2 diabetes, use IMS. The major objective of the project is to analyse the impact of a peer supported IMS intervention in addition to a standard diabetes therapy on the glycaemic control of type 2 diabetic patients. A total of 205 participants (196 participants and 9 moderators) with type 2 diabetes mellitus, older than 40 years will be included and randomly assigned to the intervention or control group. Both groups will receive standard therapy, but the intervention group will use the peer support IMS tool, additionally. The duration of the intervention will last for seven months, followed by a follow-up of seven months. Biochemical, behavioural, and psychosocial parameters will be measured before, in the middle, and after the intervention as well as after the follow-up.


Eligibility criteria: Inclusion criteria participants exclusive moderators:

* diagnosed type 2 diabetes mellitus according to the Austrian definition
* HbA1c of ≥ 6.5% (48 mmol/mol) at the last measurement
* receive the antidiabetic therapy according to the current guidelines
* older than 40 years
* living in Lower Austria
* get oral hyperglycaemic agents for maximum three years
* understand the individual commitments during trial
* must be able to visit training and measurements

Inclusion criteria moderators:

* diagnosed type 2 diabetes mellitus according to the Austrian definition
* HbA1c of ≥ 6.5% (48 mmol/mol) at the last measurement
* receive the antidiabetic therapy according to the current guidelines
* get oral hyperglycaemic agents for three years minimum
* older than 60 years
* living in the vicinity of the training location in St. Pölten, which means residing in St. Pölten, St. Pölten Land, Melk, Krems, or Lilienfeld
* engaged participating (= regular participation) in the Austrian disease management program 'Therapie aktiv - Diabetes im Griff'
* understand the individual commitments during trial
* must be able to visit training and measurements
* commitment to undergo the moderator training

Exclusion Criteria for all participants:

* hospitalization of more than 3 weeks during the intervention
* eye disorders that severely limit vision and, hence, inability to read the display (e.g., proliferative retinopathy or macular edema)
* severe illnesses such as kidney, liver, heart disease, or malignant cancer, neurological of mental illness which make a longer hospitalization likely
* substance abuse
* pregnancy
* limitation in the German language
* unable to visit training and measurements

Primary outcomes:
measure: HbA1c [%] (change over a period of 7 months intervention and 7 months follow-up with 4 measurement dates)
timeFrame: at baseline, three months after the start of the intervention, at the end of the intervention = seven months after the start of the intervention, follow-up = 14 months after the start of the intervention
Secondary outcomes:
measure: Quality of life measured by Short-Form-Health Survey (SF-12) (change over a period of 7 months intervention and 7 months follow-up with 4 measurement dates)
timeFrame: at baseline, three months after the start of the intervention, at the end of the intervention = seven months after the start of the intervention, follow-up = 14 months after the start of the intervention
measure: Medication adherence measured by A-14 (change over a period of 7 months intervention and 7 months follow-up with 4 measurement dates)
timeFrame: at baseline, three months after the start of the intervention, at the end of the intervention = seven months after the start of the intervention, follow-up = 14 months after the start of the intervention
measure: Diabetes self-management behaviors measured by 'Summary of Diabetes Self-Care Activities German' (SDSCA-G) (change over a period of 7 months intervention and 7 months follow-up with 4 measurement dates)
timeFrame: at baseline, three months after the start of the intervention, at the end of the intervention = seven months after the start of the intervention, follow-up = 14 months after the start of the intervention
measure: Diabetes knowledge will be measured using the 'Diabetes Knowledge Test' (DKT)
timeFrame: at baseline, three months after the start of the intervention, at the end of the intervention = seven months after the start of the intervention, follow-up = 14 months after the start of the intervention
measure: Diabetes distress will be measure using the 'Diabetes Distress Scale' (DDS)
timeFrame: at baseline, three months after the start of the intervention, at the end of the intervention = seven months after the start of the intervention, follow-up = 14 months after the start of the intervention
measure: Depression will be measured using the 'Patient Health Questionnaire-9' (PHQ-9)
timeFrame: at baseline, three months after the start of the intervention, at the end of the intervention = seven months after the start of the intervention, follow-up = 14 months after the start of the intervention
measure: Social support will be measured using the 'Fragebogen zur Sozialen Unterstützung' (F-SozU)
timeFrame: at baseline, three months after the start of the intervention, at the end of the intervention = seven months after the start of the intervention, follow-up = 14 months after the start of the intervention
measure: Dietary behaviour will be measured using a Food Frequency Questionnaire
timeFrame: at baseline, three months after the start of the intervention, at the end of the intervention = seven months after the start of the intervention, follow-up = 14 months after the start of the intervention
measure: Physical activity will be measured using the 'International Physical Activity Questionnaire Short Form' (IPAQ-SF)
timeFrame: at baseline, three months after the start of the intervention, at the end of the intervention = seven months after the start of the intervention, follow-up = 14 months after the start of the intervention
measure: Biochemical parameters
timeFrame: at baseline, three months after the start of the intervention, at the end of the intervention = seven months after the start of the intervention, follow-up = 14 months after the start of the intervention
Other outcomes:
Locations:
city: St. Pölten
country: Austria
facility: Sankt Pölten University of Applied Sciences
state: Lower Austria
Study officials:
References:
citation: Hold E, Grublbauer J, Wiesholzer M, Wewerka-Kreimel D, Stieger S, Kuschei W, Kisser P, Gutzer E, Hemetek U, Ebner-Zarl A, Pripfl J. Improving glycemic control in patients with type 2 diabetes mellitus through a peer support instant messaging service intervention (DiabPeerS): study protocol for a randomized controlled trial. Trials. 2022 Apr 14;23(1):308. doi: 10.1186/s13063-022-06202-2.