Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06445725
Status:
RECRUITING
Last Update Posted:
2024-06-06
First Post:
2024-04-18
Brief Title:
Acceptance Based Coping Skills for Diabetes Delivered By Promotores
Sponsor:
Baylor College of Medicine
Organization:
Baylor College of Medicine
Study Overview
Official Title:
Acceptance Based Coping ABaCo Skills Delivered By Promotores for HispanicLatino Patients With Type 2 Diabetes
Status:
RECRUITING
Status Verified Date:
2024-06
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:
ABaCo
Brief Summary:
The goal of this pilot clinical trial is to learn about the feasibility and acceptability of promotores community health workers delivering an educational intervention for HispanicLatino patients with type 2 diabetes
The main questions it aims to answer are
1 What is the impact of the ABaCo program on participants blood sugar management and quality of life
2 How well are we able to enroll participants and keep them in the ABaCo program
3 Is this telephone-based educational ABaCo program acceptable
Participants will be asked to
Participate in four research visits provide fingerstick blood samples before and after the program at 6 months and complete questionnaires at four times times during the program before twice during and at 6 months
Participate in the ABaCo program join seven 7 individual phone call visits with promotores to review educational information about caring for diabetes while keeping connected to life values Each phone call lasts approximately 45 minutes once per week for six 6 weeks then a refresher visit is a month later
The main questions it aims to answer are
1 What is the impact of the ABaCo program on participants blood sugar management and quality of life
2 How well are we able to enroll participants and keep them in the ABaCo program
3 Is this telephone-based educational ABaCo program acceptable
Participants will be asked to
Participate in four research visits provide fingerstick blood samples before and after the program at 6 months and complete questionnaires at four times times during the program before twice during and at 6 months
Participate in the ABaCo program join seven 7 individual phone call visits with promotores to review educational information about caring for diabetes while keeping connected to life values Each phone call lasts approximately 45 minutes once per week for six 6 weeks then a refresher visit is a month later
Detailed Description:
This overall project aims to develop an acceptable and feasible Promotores-delivered intervention program for HispanicLatino patients with type 2 diabetes Specifically this study aims to conduct a mixed-methods single arm pre-post intervention pilot trial 6 months on the Acceptance Based Coping ABaCo program to
Evaluate feasibility recruitment and retention and acceptability satisfaction
Establish methods of assessing intervention fidelity
Engage multi-level partners
Estimate the magnitude of potential impact of ABaCo on selected mechanisms and outcomes
Hypothesis Participants receiving ABaCo will evidence clinically meaningful change from baseline to follow-up on glycemic management and quality of life primary outcomes and self-management skills and acceptance coping secondary outcomes
Procedures Potential participants will be referred to study staff by the Promotores team at the University Health Robert B Green Campus Family Health Center They will be contacted by study staff for a phone visit to conduct screening procedures If eligible they will be scheduled for an in-person visit at the Texas Diabetes Institute TDI where they will be consented complete a fingerstick HbA1c test and complete an initial assessment packet Participants will then receive the intervention telephone-delivered ABaCo skills program delivered by one Promotora for 6 weeks and again at week 10 booster visit There will be phone-based assessments visit at week 6 and again at week 10 They will be invited to participate in an interview to provide feedback on their experiences in the program and study A final in-person assessment at TDI will be conducted at 24 weeks 6 months after baseline including a fingerstick HbA1c test and a final assessment packet
At the study conclusion all engaged Promotores and clinical partners will also be invited to share their experiences via written and verbal feedback
Evaluate feasibility recruitment and retention and acceptability satisfaction
Establish methods of assessing intervention fidelity
Engage multi-level partners
Estimate the magnitude of potential impact of ABaCo on selected mechanisms and outcomes
Hypothesis Participants receiving ABaCo will evidence clinically meaningful change from baseline to follow-up on glycemic management and quality of life primary outcomes and self-management skills and acceptance coping secondary outcomes
Procedures Potential participants will be referred to study staff by the Promotores team at the University Health Robert B Green Campus Family Health Center They will be contacted by study staff for a phone visit to conduct screening procedures If eligible they will be scheduled for an in-person visit at the Texas Diabetes Institute TDI where they will be consented complete a fingerstick HbA1c test and complete an initial assessment packet Participants will then receive the intervention telephone-delivered ABaCo skills program delivered by one Promotora for 6 weeks and again at week 10 booster visit There will be phone-based assessments visit at week 6 and again at week 10 They will be invited to participate in an interview to provide feedback on their experiences in the program and study A final in-person assessment at TDI will be conducted at 24 weeks 6 months after baseline including a fingerstick HbA1c test and a final assessment packet
At the study conclusion all engaged Promotores and clinical partners will also be invited to share their experiences via written and verbal feedback
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