N/A
N=10
Brief CBT Interventions Delivered by Nurse Care Managers to Improve Type 2 Diabetes Outcomes: Pilot Study
Diabetes Mellitus, Type 2
Bottom Line
View on ClinicalTrials.gov: NCT02081573 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Mar 2018
Primary outcome: Primary: Acceptability Questionnaire. — 2.49 mean of scale items
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Brief CBT (Behavioral)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- University of Pittsburgh
- Primary completion
- Jul 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Acceptability Questionnaire. |
2.49 | — |
| SECONDARY Morisky Questionnaire |
.10 | — |
| SECONDARY Diabetes Distress Scale |
-.77 | — |
| SECONDARY Medication Beliefs Scale |
— | — |
| SECONDARY HbA1c Level |
-.22 | — |
| SECONDARY Body Mass Index |
-1.22 | — |
Summary
Primary aim: examine feasibility and acceptability of a brief cognitive therapy protocol for type II diabetes administered by nurse care managers or health coaches via phone.
Eligibility Criteria
Inclusion Criteria
Ten adults will be recruited through the UPMC health plan and are treated at a primary care center. To be considered for inclusion subjects must:
- have a diagnosis of T2DM;
- have a score of >3 on the Diabetes Distress Scale;
- be taking at least one oral antihyperglycemic agent (the patient may also be using injectable antihyperglycemic medications, including insulin);
- have an HbA1c level of greater than 8 at baseline;
- be receiving treatment for T2DM in the primary care setting;
- be aged 30 - 65 years and
- be able to read at the 8th-grade level and to provide informed consent.
Four nurse care managers will also be recruited from UPMC Health Care. To be considered they must be employed at UPMC Health Care and
- Have received the Brief CBT Training that was given in Phase I of this study;
- Be identified as a RN or a RN who is a diabetes nurse educator; and have Nurse Care Management responsibilities with patients who have Type 2 Diabetes.
Nurses will be excluded from the study if:
- They did not successfully complete the training in Phase I or
- Are not Nurse Care Managers at UPMC Health Care. -
Exclusion Criteria
The following are exclusion criteria:
- major psychiatric disorder and suicidal risk;
- dementia or disorders with substantial cognitive impairment. -
Data sourced from ClinicalTrials.gov (NCT02081573). 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.