Improving Glycaemic Control in Patients With Type 2 Diabetes Mellitus Through Peer Support Instant Messaging (DiabPeerS)

• ClinicalTrials.gov Identifier: NCT04797429
• Recruitment Status: Enrolling by invitation
• First Posted: March 15, 2021
• Last Update Posted: October 6, 2021
• Sponsor: St. Pölten University of Applied Sciences
• Collaborators: Karl Landsteiner University of Health Sciences; Austrian Health Insurance Fund
• Information provided by (Responsible Party): St. Pölten University of Applied Sciences

Study Description

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. These health consequences produce significant health care costs. 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.

Condition or disease	Intervention/treatment	Phase
Diabetes Mellitus, Type 2; Peer Support; Instant Messaging Service	Other: Peer Support Intervention via Instant Messaging Service Tool (IMS-Tool); Other: antidiabetic therapy according to the current guidelines	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 205 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Masking Description: blinding is not possible because of obvious differences between the interventions: the intervention group participates in the IMS-intervention and the control group does not
• Primary Purpose: Supportive Care
• Official Title: Improving Glycaemic Control in Patients With Type 2 Diabetes Mellitus Through Peer Support Instant Messaging: a Randomized Controlled Trial
• Actual Study Start Date: November 1, 2020
• Estimated Primary Completion Date: November 2023
• Estimated Study Completion Date: April 2024

Arms and Interventions

Arm	Intervention/treatment
Experimental: intervention group; The intervention group will receive antidiabetic therapy according to the current guidelines but with the additional opportunity to use the peer support IMS tool. Peer support and moderation of the intervention group will be provided by moderators. Moderators will be supervised by a dietitian.	Other: Peer Support Intervention via Instant Messaging Service Tool (IMS-Tool); Peer Support via the IMS-tool increases diabetes self-management, improves self-efficiacy, adherence and glycaemic control
Active Comparator: control group; The control group receives the antidiabetic therapy according to the current guidelines, but without having access to the IMS tool. This means that participants receive medical treatment by their practitioner according to the Austrian recommendations.	Other: antidiabetic therapy according to the current guidelines; In contrast, the control group has to manage their diabetes mellitus type 2 with standard support and without online exchange.

Outcome Measures

Primary Outcome Measures :

1. HbA1c [%] (change over a period of 7 months intervention and 7 months follow-up with 4 measurement dates) [ Time Frame: 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 ]
   HbA1c = glycated haemoglobin reflects average plasma glucose over the previous 8-12 weeks. It can be tested at any time of the day and does not require special preparation like fasting
2. Quality of health 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) [ Time Frame: 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 ]
   Quality of life will be measured using the 'Short-Form-Health Survey' (SF-12): the SF-12 includes eight dimensions ('physical functioning', 'role limitations due to physical problems', 'bodily pain', 'vitality', 'general health perceptions' , 'social functioning', 'role limitations due to emotional problems', 'mental health'). The summary scores 'physical component summary' and 'mental component summary' (0-100 scales) can be calculated from the specified scales.
3. Medication adherence measured by A-14 (change over a period of 7 months intervention and 7 months follow-up with 4 measurement dates) [ Time Frame: 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 ]
   Medication adherence will be measured using the 'A14-scale': the A14 consists of 14 items of non-adherent behaviors phrased in a non-threatening and non-judgemental way using a five-item Likert scale with the endpoints '4' (never) to '0' (very often).
4. 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) [ Time Frame: 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 ]
   Diabetes self-management behaviors will be measured using the 'Summary of Diabetes Self-Care Activities German' (SDSCA-G): the SDSCA-G focuses on the past seven days related to the diabetes self-care activities 'nutrition', 'physical activities', 'blood glucose testing', 'foot care', and 'smoking'.

Secondary Outcome Measures :

1. Assess the association between specific personality traits and benefits of peer supported IMS [ Time Frame: 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 ]

   Correlation of Extroversion measured by Big Five Inventory German (BFI-2) and the frequency of IMS-usage, perceived helpfulness of peer supported IMS and HbA1c level.

   Personal traits will be assessed using the Big Five Inventory German (BFI-2). The BFI-2 captures 'extraversion', 'agreeableness', 'conscientiousness', 'negative emotionality' and 'openness', each represented by three sub-facets. The BFI-2 consists of 60 items using a five-item Likert scale with the endpoints '1' (strongly disagree) to '5' (strongly agree).

Eligibility Criteria

• Ages Eligible for Study: 40 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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 one year
• 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:

• neurological or mental illness
• 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, which make a longer hospitalization likely
• substance abuse
• pregnancy
• limitation in the German language
• unable to visit training and measurements

Contacts and Locations

Locations

Austria

Sankt Pölten University of Applied Sciences

St. Pölten, Lower Austria, Austria, 3100

Sponsors and Collaborators

St. Pölten University of Applied Sciences

Karl Landsteiner University of Health Sciences

Austrian Health Insurance Fund

More Information

• Responsible Party: St. Pölten University of Applied Sciences
• ClinicalTrials.gov Identifier: NCT04797429
• Other Study ID Numbers: LS18-021
• First Posted: March 15, 2021
• Last Update Posted: October 6, 2021
• Last Verified: September 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by St. Pölten University of Applied Sciences:

Diabetes Mellitus Type 2; Online Intervention; Peer Support; Instant Messaging Service; Glycaemic Control

Additional relevant MeSH terms:

Diabetes Mellitus; Diabetes Mellitus, Type 2; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Hypoglycemic Agents; Physiological Effects of Drugs