Ignite Creation Date:
2024-05-05 @ 4:49 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00320112
Status:
COMPLETED
Last Update Posted:
2015-04-24
First Post:
2006-04-27
Brief Title:
Improving Insulin Therapy With Enhanced Care Management
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Improving Insulin Therapy With Enhanced Care Management and Peer Support
Status:
COMPLETED
Status Verified Date:
2014-08
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:
None
Brief Summary:
VA diabetes patients often have difficulty managing their self-care and accessing clinic-based services many also lack social support to help them meet the demands of their illness Enhanced support is especially important when undertaking and sustaining new challenging self-care tasks such as initiating or intensifying insulin treatment regimens Although some VAs have implemented telephone nurse care management programs supported by automated calling services many are reluctant to adopt these models due to nursing shortages
Detailed Description:
Background
VA diabetes patients often have difficulty managing their self-care and accessing clinic-based services many also lack social support to help them meet the demands of their illness Enhanced support is especially important when undertaking and sustaining new challenging self-care tasks such as initiating or intensifying insulin treatment regimens Although some VAs have implemented telephone nurse care management programs supported by automated calling services many are reluctant to adopt these models due to nursing shortages
Objectives
This randomized trial will evaluate an intervention using a low-cost interactive voice response IVR exchange system to promote peer-to-peer communication among diabetes patients initiating or increasing insulin therapy under medical guidance The intervention is based on research demonstrating the positive impact of peer support on chronic disease outcomes and self-care behaviors our own prior studies demonstrating the effectiveness of IVR-based self-management supports for VA diabetes patients and a successful pilot study demonstrating VA diabetes patients willingness to participate in IVR-facilitated peer support The Specific Aims are 1 To evaluate the effect of IVR-facilitated peer support on diabetes patients glycemic control including their A1c levels insulin doses hypo- and hyperglycemic symptoms and use of VA care 2 To assess the impact of IVR-facilitated peer support on patient-centered outcomes including patients satisfaction with care perceived social support diabetes-specific quality of life and self-care behaviors and 3 To identify patient characteristics associated with participation and use of IVR peer support and mediators of the interventions impact on patient outcomes
Methods
324 diabetes patients with inadequate glycemic control who are candidates for insulin initiation or intensification will be recruited from 2 VA facilities Ann Arbor and Toledo We will pair eligible patients based on age gender and whether they are initiating or increasing insulin Pairs will be randomized to either 1 usual care or 2 usual care in conjunction with the IVR-based peer support program After their orientation intervention participants will be asked to communicate weekly with their partner using the IVR exchange The IVR service is designed to allow patients to communicate without divulging their home phone number experiencing toll charges or being responsible for insuring that contacts occur without the assistance of reminder prompts Intervention patients who have achieved adequate glycemic control at their 6-month follow up will be encouraged to select a new treatment goal Patients will continue to participate in weekly IVR calls for 6 months Research staff will monitor the process via the Internet and outcomes will be measured at six months The primary endpoint will be HbA1c levels at 6 and 12-months Secondary endpoints include other physiological measures and patient-centered outcomes The intervention is designed to interact with standard outpatient VA staffing models We will develop detailed training materials that facilitate implementation in other facilities and work with clinical managers to facilitate roll-out if the intervention is found to be effective
Status
Recruitment of participants is complete as well as most preliminary data analyses 12 month data is now being analyzed
VA diabetes patients often have difficulty managing their self-care and accessing clinic-based services many also lack social support to help them meet the demands of their illness Enhanced support is especially important when undertaking and sustaining new challenging self-care tasks such as initiating or intensifying insulin treatment regimens Although some VAs have implemented telephone nurse care management programs supported by automated calling services many are reluctant to adopt these models due to nursing shortages
Objectives
This randomized trial will evaluate an intervention using a low-cost interactive voice response IVR exchange system to promote peer-to-peer communication among diabetes patients initiating or increasing insulin therapy under medical guidance The intervention is based on research demonstrating the positive impact of peer support on chronic disease outcomes and self-care behaviors our own prior studies demonstrating the effectiveness of IVR-based self-management supports for VA diabetes patients and a successful pilot study demonstrating VA diabetes patients willingness to participate in IVR-facilitated peer support The Specific Aims are 1 To evaluate the effect of IVR-facilitated peer support on diabetes patients glycemic control including their A1c levels insulin doses hypo- and hyperglycemic symptoms and use of VA care 2 To assess the impact of IVR-facilitated peer support on patient-centered outcomes including patients satisfaction with care perceived social support diabetes-specific quality of life and self-care behaviors and 3 To identify patient characteristics associated with participation and use of IVR peer support and mediators of the interventions impact on patient outcomes
Methods
324 diabetes patients with inadequate glycemic control who are candidates for insulin initiation or intensification will be recruited from 2 VA facilities Ann Arbor and Toledo We will pair eligible patients based on age gender and whether they are initiating or increasing insulin Pairs will be randomized to either 1 usual care or 2 usual care in conjunction with the IVR-based peer support program After their orientation intervention participants will be asked to communicate weekly with their partner using the IVR exchange The IVR service is designed to allow patients to communicate without divulging their home phone number experiencing toll charges or being responsible for insuring that contacts occur without the assistance of reminder prompts Intervention patients who have achieved adequate glycemic control at their 6-month follow up will be encouraged to select a new treatment goal Patients will continue to participate in weekly IVR calls for 6 months Research staff will monitor the process via the Internet and outcomes will be measured at six months The primary endpoint will be HbA1c levels at 6 and 12-months Secondary endpoints include other physiological measures and patient-centered outcomes The intervention is designed to interact with standard outpatient VA staffing models We will develop detailed training materials that facilitate implementation in other facilities and work with clinical managers to facilitate roll-out if the intervention is found to be effective
Status
Recruitment of participants is complete as well as most preliminary data analyses 12 month data is now being analyzed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None