Ignite Creation Date:
2024-05-06 @ 3:18 PM
Last Modification Date:
2024-10-26 @ 1:47 PM
Study NCT ID:
NCT04587336
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-22
First Post:
2020-10-07
Brief Title:
Tailored Approaches to Reduce Distress and Improve Self-Management for Veterans With Diabetes
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Tailored Approaches to Reduce Distress and Improve Self-Management for Veterans With Diabetes TARDIS
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
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:
TARDIS
Brief Summary:
Veterans with diabetes may become overwhelmed with the self-management behaviors needed to maintain optimal health Veterans may experience diabetes distress DD a concept distinct from depression due the amount and frequency of these behaviors DD negatively influences the Veterans engagement in self-management and subsequent HbA1c levels Previous interventions do not tailor T2D self-management information to a Veterans DD which may be one reason interventions are ineffective at reducing DD This proposal examines the impact of correlating factors eg sociodemographic psychosocial and environmental on DD using surveys and semi-structured interviews Then these findings will be used to design and test an intervention that provides T2D self-management information in conjunction with facilitating a connection to supportive services tailored to a Veterans DD This proposal will prepare Allison Lewinski PhD MPH RN for a career as a scientist at VHA focused on developing methods to improve health outcomes among Veterans
Detailed Description:
Background Diabetes self-management is critical to sustaining optimal health following diagnosis Diabetes distress DD is a crucial factor that influences a Veterans engagement in diabetes self-management DD is distinct from depression and includes four domains ie regimen emotional interpersonal healthcare provider The presence of DD negatively impacts engagement in self-management and HbA1c Despite interventions aimed at decreasing DD these interventions have shown minimal lasting effects One reason may be because interventions do not tailor information to an individuals DD
Significance Impact This proposal will be the first to examine the impact of correlating factors on DD and then design and test a self-management intervention tailored upon a Veterans DD type This proposal addresses the VHA Strategic Plan Priority areas of utilizing resources more efficiently and improving the timeliness of services and the HSRD Research Priorities of Population HealthWhole Health and Primary Care Practice This proposals findings can improve both care delivery and health outcomes of Veterans as the investigator will help facilitate the Veterans linkage to ubiquitous existing VHA and community services
Innovation This proposal will develop an intervention that targets sub-optimal T2D self-management by providing tailored self-management information in conjunction with connections to supportive services The investigators will identify how and to what extent DD and its factors influence a Veterans self-management behaviors
Specific Aims Aim 1 will examine the association of psychosocial factors depression PTSD environmental factors finances support self-management behaviors and HbA1c with DD These Aim 1 data will inform the identification of modifiable factors and selection of the population for a diabetes self-management intervention for Veterans with T2D Aim 2 will describe self-management challenges and preferred learning strategies to inform the intervention components and delivery approach for Veterans with T2D Obtaining in-depth perceptions of DD type self-management strategies and challenges and learning preferences is essential to tailoring intervention components Aim 3a photo elicitation the purpose of this research study is to further understand DD by expanding on what we have learned thus far in cognitive and semi-structured interviews with Veterans The purpose of Aim 3b is to design pilot test an innovative tailored T2D self-management information and supportive services intervention for Veterans with T2D to promote engagement in self-management behaviors In Aim 3b the investigators will determine the feasibility and acceptability of the intervention for Veterans with T2D
Methodology This proposal uses an explanatory sequential mixed-methods design to describe DD in a sample of Veterans who receive care at Durham In Aim 1 the investigators will survey Veterans n 200 and balance enrollment by HbA1C 9 or 9 and medication use insulin no insulin In Aim 2 the investigators will conduct semi-structured interviews with a sub-sample n 36 of Veterans surveyed in Aim 1 The investigators will balance enrollment by HbA1C medication use and DD level as operationalized by the Diabetes Distress Scale low moderate high In Aim 3a the photo elicitation study we will consent up to 50 Veterans in order to enroll 30 Veterans with HbA1c 8 type 2 diabetes only to receive TARDIS in addition to standard VHA care HT care coordination and telemonitoring The Veteran would be provided with a camera and instructed to take approximately 20 photos over two weeks We would conduct two semi-structured interviews with the Veteran to discuss this experience Visual-based qualitative methods will help us identify and more robustly describe DD in Veterans In Aim 3b the investigators will develop and refine the intervention using findings from Aims 1 2 and strategies successfully used by co-mentors To develop the intervention the investigators will conduct semi-structured interviews with stakeholders n 20 physicians nurses administrators to review components eg learning approaches relevant VAcommunity resources to ensure relevancy The investigators will modify components and the delivery strategy as needed Then will test the intervention with 30 Veterans to evaluate feasibility and acceptability and utilization of recommended supportive services using quantitative and qualitative approaches
Implementation Next Steps The next steps include dissemination of findings about DD and its correlates and the development of an IIR This IIR will be a Phase III efficacy trial and will be sufficiently powered to test the effects of providing self-management information and connections to supportive services tailored to a Veterans DD to improve HbA1c
Significance Impact This proposal will be the first to examine the impact of correlating factors on DD and then design and test a self-management intervention tailored upon a Veterans DD type This proposal addresses the VHA Strategic Plan Priority areas of utilizing resources more efficiently and improving the timeliness of services and the HSRD Research Priorities of Population HealthWhole Health and Primary Care Practice This proposals findings can improve both care delivery and health outcomes of Veterans as the investigator will help facilitate the Veterans linkage to ubiquitous existing VHA and community services
Innovation This proposal will develop an intervention that targets sub-optimal T2D self-management by providing tailored self-management information in conjunction with connections to supportive services The investigators will identify how and to what extent DD and its factors influence a Veterans self-management behaviors
Specific Aims Aim 1 will examine the association of psychosocial factors depression PTSD environmental factors finances support self-management behaviors and HbA1c with DD These Aim 1 data will inform the identification of modifiable factors and selection of the population for a diabetes self-management intervention for Veterans with T2D Aim 2 will describe self-management challenges and preferred learning strategies to inform the intervention components and delivery approach for Veterans with T2D Obtaining in-depth perceptions of DD type self-management strategies and challenges and learning preferences is essential to tailoring intervention components Aim 3a photo elicitation the purpose of this research study is to further understand DD by expanding on what we have learned thus far in cognitive and semi-structured interviews with Veterans The purpose of Aim 3b is to design pilot test an innovative tailored T2D self-management information and supportive services intervention for Veterans with T2D to promote engagement in self-management behaviors In Aim 3b the investigators will determine the feasibility and acceptability of the intervention for Veterans with T2D
Methodology This proposal uses an explanatory sequential mixed-methods design to describe DD in a sample of Veterans who receive care at Durham In Aim 1 the investigators will survey Veterans n 200 and balance enrollment by HbA1C 9 or 9 and medication use insulin no insulin In Aim 2 the investigators will conduct semi-structured interviews with a sub-sample n 36 of Veterans surveyed in Aim 1 The investigators will balance enrollment by HbA1C medication use and DD level as operationalized by the Diabetes Distress Scale low moderate high In Aim 3a the photo elicitation study we will consent up to 50 Veterans in order to enroll 30 Veterans with HbA1c 8 type 2 diabetes only to receive TARDIS in addition to standard VHA care HT care coordination and telemonitoring The Veteran would be provided with a camera and instructed to take approximately 20 photos over two weeks We would conduct two semi-structured interviews with the Veteran to discuss this experience Visual-based qualitative methods will help us identify and more robustly describe DD in Veterans In Aim 3b the investigators will develop and refine the intervention using findings from Aims 1 2 and strategies successfully used by co-mentors To develop the intervention the investigators will conduct semi-structured interviews with stakeholders n 20 physicians nurses administrators to review components eg learning approaches relevant VAcommunity resources to ensure relevancy The investigators will modify components and the delivery strategy as needed Then will test the intervention with 30 Veterans to evaluate feasibility and acceptability and utilization of recommended supportive services using quantitative and qualitative approaches
Implementation Next Steps The next steps include dissemination of findings about DD and its correlates and the development of an IIR This IIR will be a Phase III efficacy trial and will be sufficiently powered to test the effects of providing self-management information and connections to supportive services tailored to a Veterans DD to improve HbA1c
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?:
False
Is an FDA AA801 Violation?:
None