Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06419907
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-05-17
First Post:
2024-05-09
Brief Title:
Differing Completion Rates of DIABETES Education on Patient Reported Outcomes
Sponsor:
University of Liverpool
Organization:
University of Liverpool
Study Overview
Official Title:
A Feasibility Study Evaluating the Impact of Differing Completion Rates of a Face-to-face Diabetes Self-management Education Programme on Patient Reported Outcome Measures
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-08
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:
DIABETES-PRO
Brief Summary:
The goal of this clinical feasibility trial is to test the impact of differing completion rates of a face-to-face diabetes self-management education programme on patient-reported outcomes measuring self-care diabetes distress and quality of life in people with type 2 diabetes The main question it aims to answer is
1 What is the impact of differing completion rates of DSME programmes on ability to self-care primary outcome diabetes distress and health related quality of life in type 2 diabetes
Researchers will compare participants across four study groups Group 1 will receive a full DSME programme Group 2 will receive 60 Group 3 will receive 10 and Group 4 will have delayed education to see if patients who attend minimal aspects 10 of diabetes self-management education programmes gain clinically significant improvements in ability to self-care compared to those who do not attend and if the nationally accepted 60 completion rate is as effective as 100 completion
Participants will
complete three validated patient reported outcome measures testing self care activities diabetes distress and health related quality of life
Attend structured diabetes self-management education of differing completion rates dependent on the group they have been allocated to
repeat the same three patient reported outcome measures 2-4 months after intervention For participants in group 4 this will be 3-4 months from baseline
1 What is the impact of differing completion rates of DSME programmes on ability to self-care primary outcome diabetes distress and health related quality of life in type 2 diabetes
Researchers will compare participants across four study groups Group 1 will receive a full DSME programme Group 2 will receive 60 Group 3 will receive 10 and Group 4 will have delayed education to see if patients who attend minimal aspects 10 of diabetes self-management education programmes gain clinically significant improvements in ability to self-care compared to those who do not attend and if the nationally accepted 60 completion rate is as effective as 100 completion
Participants will
complete three validated patient reported outcome measures testing self care activities diabetes distress and health related quality of life
Attend structured diabetes self-management education of differing completion rates dependent on the group they have been allocated to
repeat the same three patient reported outcome measures 2-4 months after intervention For participants in group 4 this will be 3-4 months from baseline
Detailed Description:
Structured diabetes self-management education DSME is internationally recommended for all people with newly diagnosed type 2 diabetes and is designed to support patients in self-managing their condition and prevent associated long-term complications DSME is proven to be as effective as pharmacotherapy in preventing diabetes associated morbidity and premature mortality but attendance at both a national and local level remains poor Local records suggest that of those that start DSME 9 only 126 complete the programme Attendance at DSME is currently benchmarked as having completed a registration form and had at least one active engagement with a programmes content with completion measured against 60 completion despite landmark trials reporting outcomes based on the full completion of a programme Little is known of the effectiveness of DSME on the psychological and emotional health of people with diabetes who complete less than the full DSME programme
This feasibility study will test the impact of differing completion rates of a face-to-face DSME programme on patient reported outcomes measuring self-care diabetes distress and quality of life in people with type 2 diabetes
Using a quantitative approach a single centre randomised feasibility study will be conducted aiming to recruit 120 eligible people with type 2 diabetes due to attend a secondary care diabetes clinic in the Northwest UK for specialist support education and advice Participants will be randomised into one of four groups Group 1 will receive a full DSME programme Group 2 will receive 60 Group 3 will receive 10 and Group 4 will have delayed education Normal clinical care will continue Preliminary outcomes psychometric questionnaire scores measuring ability to self-care diabetes distress and health related quality of life will be evaluated at baseline and 3-4 months post-intervention Measures of feasibility eligibility recruitment and retention rates will be reported
Whilst the current literature evidences the clear benefits for people with type 2 diabetes attending DSME programmes there is minimal understanding of the benefits of partial DSME completion on a persons ability to self-care despite national consensus accepting 60 attendance as completed The proposed research aims to test the feasibility of conducting a full randomised control trial to evaluate the effectiveness of DSME programmes on psychometric outcomes with differing completion rates
This feasibility study will test the impact of differing completion rates of a face-to-face DSME programme on patient reported outcomes measuring self-care diabetes distress and quality of life in people with type 2 diabetes
Using a quantitative approach a single centre randomised feasibility study will be conducted aiming to recruit 120 eligible people with type 2 diabetes due to attend a secondary care diabetes clinic in the Northwest UK for specialist support education and advice Participants will be randomised into one of four groups Group 1 will receive a full DSME programme Group 2 will receive 60 Group 3 will receive 10 and Group 4 will have delayed education Normal clinical care will continue Preliminary outcomes psychometric questionnaire scores measuring ability to self-care diabetes distress and health related quality of life will be evaluated at baseline and 3-4 months post-intervention Measures of feasibility eligibility recruitment and retention rates will be reported
Whilst the current literature evidences the clear benefits for people with type 2 diabetes attending DSME programmes there is minimal understanding of the benefits of partial DSME completion on a persons ability to self-care despite national consensus accepting 60 attendance as completed The proposed research aims to test the feasibility of conducting a full randomised control trial to evaluate the effectiveness of DSME programmes on psychometric outcomes with differing completion rates
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 337691 | OTHER | IRAS | None |