Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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 intervention's 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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reciprocal Diabetes Peer Support program | Experimental | peers are paired during the group visit and are encouraged to speak with their partner at least once a week for the 6 month duration of the study. |
|
| Nurse Case Management | Other | patients are not paired in the NCM arm. they are provided with educational session on diabetes management and informed of case management services. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reciprocal Diabetes Peer Support Program | Behavioral | participants are paired with another age-matched participation. Paired peer partners were encouraged to talk weekly using a telephone platform that recorded call frequency and duration and provided automated reminders promoting peer contact. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Glycemic Control (HbA1c) | The primary outcome was change between baseline and six-month Hemoglobin A1c (HbA1c), measured with a Bayer DCA 2000+ point-of-care analyzer. | 6 months (baseline to 6 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Systolic Blood Pressure Measure | secondary outcome measure was change in blood pressure comparison of peer support group and nurse case management group from baseline to six months | change in blood pressure at 6 months |
| Change in Diastolic Blood Pressure |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| John D. Piette, PhD | VA Ann Arbor Healthcare System, Ann Arbor, MI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Ann Arbor Healthcare System, Ann Arbor, MI | Ann Arbor | Michigan | 48105 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20956707 | Result | Heisler M, Vijan S, Makki F, Piette JD. Diabetes control with reciprocal peer support versus nurse care management: a randomized trial. Ann Intern Med. 2010 Oct 19;153(8):507-15. doi: 10.7326/0003-4819-153-8-201010190-00007. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Reciprocal Diabetes Peer Support Program (RPS) | participants in the intervention arm are paired with a peer Peer-support telephone calls: peers are paired during the group visit and are encouraged to speak with their partner at least once a week for the 6 month duration of the study. group outpatient counseling visits: participants are given the option to attend 3 optional group visits with other participants and case managers. this gives them the opportunity to ask any diabetes related questions of nurses or other participants who have diabetes. |
| FG001 | Nurse Case Management | participants were randomized to receive usual care with an initial educational session to review lab results and discuss any questions related to educational handouts. particpants were also provided information about nurse case managements services and encouraged to use the service regularly. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
125 participants were randomized to Reciprocal Peer Support (RPS), and 119 to Nurse case management (NCM).
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Receiprocal Peer Support | participants in the intervention arm are paired with a peer Peer-support telephone calls: peers are paired during the group visit and are encouraged to speak with their partner at least once a week for the 6 month duration of the study. group outpatient counseling visits: participants are given the option to attend 3 optional group visits with other participants and case managers. this gives them the opportunity to ask any diabetes related questions of nurses or other participants who have diabetes. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Glycemic Control (HbA1c) | The primary outcome was change between baseline and six-month Hemoglobin A1c (HbA1c), measured with a Bayer DCA 2000+ point-of-care analyzer. | Peer Support group: 117 of the 125 provided 6 month data and 113 provided physiologic measures. Nurse Case management participants: 114 of 119 provided 6 month data and 103 provided follow-up physiologic measures. | Posted | Mean | Standard Deviation | percent HbA1c | 6 months (baseline to 6 months) |
|
adverse event information was collected through-out the course of a participants enrollment in the study - 6 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Reciprocal Peer Support Intervention | participants in the intervention arm are paired with a peer Peer-support telephone calls: peers are paired during the group visit and are encouraged to speak with their partner at least once a week for the 6 month duration of the study. group outpatient counseling visits: participants are given the option to attend 3 optional group visits with other participants and case managers. this gives them the opportunity to ask any diabetes related questions of nurses or other participants who have diabetes. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders | death | Systematic Assessment | Cause of death was unknown to study team |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Fatima Makki | VA HSRD | 734 845 3623 | Fatima.Makki@va.gov |
Not provided
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Nurse Case management | Behavioral | patients are not paired in the NCM arm attended a 1.5 hour session to receive education on care manager services and diabetes educational materials and be assigned to a nurse care manager with whom they were encouraged to follow-up regularly. |
|
| group outpatient counseling visits | Behavioral | Participants in the peer group were also offered three optional 1.5 hour patient-driven group sessions at month 1, 3, and 6 |
|
change in diastolic blood pressure was measured at 6 months |
| 6 months from baseline |
| Number of Participants With Insulin Starts at 6 Months | the number of insulin starts at 6 months from baseline. | 6 months (baseline to 6 months follow-up) |
| Death |
|
| BG001 | Nurse Case Management | participants were randomized to receive usual care with an initial educational session to review lab results and discuss any questions related to educational handouts |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Education | Number | participants |
|
| Annual Income | Number | participants |
|
| Social Support | Number | participants |
|
| Anti-hyperglycemic Medications | Number | participants |
|
| Self-Rated General Health Status - Fair or Poor Health | Number | participants |
|
| HbA1c | Mean | Standard Deviation | percent HbA1c |
|
| Systolic Blood Pressure | Mean | Standard Deviation | mmHg |
|
| Diastolic Blood Pressure | Mean | Standard Deviation | mmHg |
|
| OG001 | Nurse Case Management Group | Nurse Case Management group was offered an educational session with nurse case managers on diabetes and informed of case management services. they were encouraged to utilize this service regularly. |
|
|
|
| Secondary | Change in Systolic Blood Pressure Measure | secondary outcome measure was change in blood pressure comparison of peer support group and nurse case management group from baseline to six months | comparison of blood pressure measure taken at baseline and then again at 6 months among the two groups. as noted, 113 peer support participants provided physiologic measures at 6 months and 103 of 119 from the nurse management group provided physiologic measures at 6 months. | Posted | Mean | Standard Deviation | mmHg | change in blood pressure at 6 months |
|
|
|
|
| Secondary | Change in Diastolic Blood Pressure | change in diastolic blood pressure was measured at 6 months | As noted earlier, for physiologic measures only 113 of the 125 peer support participants were able to provide 6 month follow-up data and 103 of 119 nurse management group provided 6 month follow-up data. | Posted | Mean | Standard Deviation | mmHg | 6 months from baseline |
|
|
|
|
| Secondary | Number of Participants With Insulin Starts at 6 Months | the number of insulin starts at 6 months from baseline. | medical charts were reviewed to obtain this information and all participant charts were reviewed | Posted | Number | participants | 6 months (baseline to 6 months follow-up) |
|
|
|
|
| 2 |
| 125 |
| 0 |
| 125 |
| EG001 | Nurse Case Management Intervention | participants were randomized to receive usual care with an initial educational session to review lab results and discuss any questions related to educational handouts | 1 | 119 | 0 | 119 |
|
Not provided
Not provided
| D006946 | Hyperinsulinism |