N/A
Completed N=1,536
Shared Health Appointments and Reciprocal Enhanced Support
Diabetes Insipidus
Source: ClinicalTrials.gov NCT02132676 ↗
Enrolled (actual)
1,536
Serious AEs
0.0%
Results posted
Aug 2020
Primary outcomePrimary: Change in Glycemic Control — 8.92; 9.12; 8.26; 8.16 % glycolated hemoglobin
Summary
The purpose of this study is to evaluate the effectiveness of a peer-to-peer program (P2P) in addition to Shared Medical Appointments (SMAs) compared to SMAs alone for the treatment of diabetes in five VA health systems, and to study the implementation process in order to gather information required to disseminate the program more broadly in the VHA system.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Glycemic Control |
8.92; 9.12; 8.26; 8.16; 8.15; 8.15 | — |
| SECONDARY Change in Systolic Blood Pressure (SBP) |
139.6; 137.2; 139.6; 136.2; 139.3; 137.4 | — |
| SECONDARY Insulin Starts |
255; 385; 247; 418; 246; 406 | — |
| SECONDARY Emergency Department (ED) Visits |
0.51; 0.54; 0.42; 0.68; 0.50; 0.60 | — |
| SECONDARY Statin Starts |
470; 603; 456; 617; 446; 608 | — |
| SECONDARY Change in Number of Classes of Anti-hypertensive Meds |
2.23; 2.38; 2.31; 2.38; 2.28; 2.39 | — |
| SECONDARY Change in Patient-reported Satisfaction With VA Care |
4.58; 4.97; 4.88 | — |
| SECONDARY Change in Patient-reported Diabetes Distress |
2.43; 2.19; 2.03 | — |
| SECONDARY Change in Patient-reported Degree of Diabetes Support |
3.77; 4.29; 4.09 | — |
| SECONDARY Change in Patient-reported Degree of Self-Efficacy |
4.51; 4.84; 4.87 | — |
| SECONDARY Hospitalizations |
0.12; 0.10; 0.12; 0.15; 0.14; 0.12 | — |
| SECONDARY Length of Hospitalizations |
6.1; 3.1; 12.7; 6.3; 7.3; 8.6 | — |
| SECONDARY PCP Visits |
1.65; 1.57; 1.04; 1.42; 1.11; 1.38 | — |
| SECONDARY Nurse Case Manager Visits |
0.40; 0.42; 0.08; 0.29; 0.18; 0.23 | — |
| SECONDARY Endocrinology Visits |
0.18; 0.21; 0.15; 0.20; 0.15; 0.21 | — |
Eligibility Criteria
Inclusion Criteria
Veterans enrolled into diabetes Shared Medical Appointments (SMAs) at participating sites, and a random subset of those meeting criteria for diabetes SMAs who have not yet participated:
- Veteran receiving care at a participating VA Medical Center
- Meets at least one of the following criteria in the past 2 years;
- at least 1 VA hospitalization with a diabetes-related International Classification Of Diseases-9 (ICD-9) code,
- at least 2 VA outpatient visits with a diabetes-related ICD-9 code, or
- At least 1 VA prescription for a glucose control medication (insulin or oral agent) or monitoring supplies
- Poor glycemic control, indicated by a HbA1c in the past 6 months or:
- at least 7.5% if age <70, or
- at least 8% if age 70+
- Has a current address and telephone number listed in VA databases
- Is competent to provide informed consent
- Can communicate in English and by telephone
- Able to participate in an outpatient program
Exclusion Criteria
For no intervention control group:
- Active substance abuse disorder (smoking cigarettes is not an exclusion)
- Serious psychiatric illness (bipolar disorder, dementia, schizophrenia, or personality disorders)
- Terminally ill
- Prisoner
Data sourced from ClinicalTrials.gov (NCT02132676). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.