Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06384521
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-04-22
Brief Title:
Lifestyle MIND- Feasibility of Wait-list Control
Sponsor:
The University of Texas Health Science Center at San Antonio
Organization:
The University of Texas Health Science Center at San Antonio
Study Overview
Official Title:
Type 2 Diabetes Prevention and Management for People With Serious Mental Illness A Feasibility Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
MIND
Brief Summary:
The goal of this clinical trial is to examine if it is feasible to randomly assign people into two groups and participate in Lifestyle MIND Mental Illness andN Diabetes at two different times Lifestyle MIND is a diabetes lifestyle intervention recently developed for people with serious mental illness SMI It is known to be helpful for people with SMI who complete it but the investigators do not know the effect in comparison to those who do not participate in it The main questions it aims to answer are
Does Lifestyle MIND improve diabetes control among people with SMI
Will the effect of Lifestyle MIND be sustained 10 weeks after program completion
From the providers perspective what are the barriers of achieving optimal diabetes treatment outcomes for patients with SMI
Researchers will compare outcomes of participants in the intervention with those in the wait-list control arm to see if there will be significant differences in blood glucose level compliance of diabetes self-management time staying active number of emergency department ED visits and psychiatric hospitalization and subjective well-being
Does Lifestyle MIND improve diabetes control among people with SMI
Will the effect of Lifestyle MIND be sustained 10 weeks after program completion
From the providers perspective what are the barriers of achieving optimal diabetes treatment outcomes for patients with SMI
Researchers will compare outcomes of participants in the intervention with those in the wait-list control arm to see if there will be significant differences in blood glucose level compliance of diabetes self-management time staying active number of emergency department ED visits and psychiatric hospitalization and subjective well-being
Detailed Description:
Specific Aims 1 and 2
Study Design
The study team will do a study called a randomized wait-list control trial This means the investigators will randomly choose who gets the program first and who waits Those in the program group will get a 10-week Lifestyle MIND program and then join a self-help group for 10 weeks The waitlist group will wait for 10 weeks and then get the 10-week Lifestyle MIND program
Participants
The study team will recruit 20 people from a program for homeless adults in San Antonio TX who often have serious mental illness SMI The study team will invite them to an information session to explain the study After agreeing to join participants will sign a form and give some basic information after which the study team will randomly assign them to either start the program right away or wait for 10 weeks
Data Collection and Analysis
The study team will collect data from all participants at the beginning after 10 weeks and after 20 weeks
Specific Aim 3
To address this aim the study team will do a qualitative study Six healthcare professionals administrators or leaders who work with people who have both serious mental illness and type 2 diabetes will be interviewed Questions asked will be
What works well for helping people with SMI manage their diabetes What challenges do they face in helping these patients What could be done to allow them help these patients obtain the best outcomes
The study team will record and write down the interviews and use a method called thematic analysis to understand the main ideas Well use a computer program called NVivo to help us with this
Study Design
The study team will do a study called a randomized wait-list control trial This means the investigators will randomly choose who gets the program first and who waits Those in the program group will get a 10-week Lifestyle MIND program and then join a self-help group for 10 weeks The waitlist group will wait for 10 weeks and then get the 10-week Lifestyle MIND program
Participants
The study team will recruit 20 people from a program for homeless adults in San Antonio TX who often have serious mental illness SMI The study team will invite them to an information session to explain the study After agreeing to join participants will sign a form and give some basic information after which the study team will randomly assign them to either start the program right away or wait for 10 weeks
Data Collection and Analysis
The study team will collect data from all participants at the beginning after 10 weeks and after 20 weeks
Specific Aim 3
To address this aim the study team will do a qualitative study Six healthcare professionals administrators or leaders who work with people who have both serious mental illness and type 2 diabetes will be interviewed Questions asked will be
What works well for helping people with SMI manage their diabetes What challenges do they face in helping these patients What could be done to allow them help these patients obtain the best outcomes
The study team will record and write down the interviews and use a method called thematic analysis to understand the main ideas Well use a computer program called NVivo to help us with this
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