Viewing Study NCT04797429



Ignite Creation Date: 2024-05-06 @ 3:53 PM
Last Modification Date: 2024-10-26 @ 1:59 PM
Study NCT ID: NCT04797429
Status: ACTIVE_NOT_RECRUITING
Last Update Posted: 2024-01-17
First Post: 2021-03-09

Brief Title: Improving Glycaemic Control in Patients With Type 2 Diabetes Mellitus Through Peer Support Instant Messaging
Sponsor: St Pölten University of Applied Sciences
Organization: St Pölten University of Applied Sciences

Study Overview

Official Title: Improving Glycaemic Control in Patients With Type 2 Diabetes Mellitus Through Peer Support Instant Messaging a Randomized Controlled Trial
Status: ACTIVE_NOT_RECRUITING
Status Verified Date: 2024-01
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: DiabPeerS
Brief Summary: Diabetes mellitus is one of the four priority non-communicable diseases worldwide Globally 425 million adults suffered from diabetes mellitus 72-113 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 patients 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
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None