Brief CBT Interventions Delivered by Nurse Care Managers to Improve Type 2 Diabetes Outcomes: Pilot Study



Status:Completed
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:30 - 65
Updated:4/17/2018
Start Date:January 2013
End Date:July 2016

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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.

A significant problem in primary care healthcare delivery is the lack of interventions to
improve medication and overall regimen adherence in persons with Type 2 diabetes (T2DM).
Diabetes distress, a negative response to the diagnosis of T2DM, danger of complications, and
self-management burdens is present in up to 70% of persons with T2DM. Distress is a
significant factor in medication nonadherence and poor glycemic control. Treatment adherence
is vital to maintain glucose control and reduce complications.

The literature has identified dysfunctional thinking patterns such as beliefs (e.g., I can't
handle taking these medications), assumptions (e.g., I know I will have side effects to these
medications) and interpretations (e.g., I'm too overwhelmed to do all of this stuff) as
critical variables that impact both distress and T2DM treatment adherence. Current treatment
strategies within primary care do not address the dysfunctional thinking patterns that affect
the patient's distress level, T2DM medication adherence, and complex daily self-care
activities.

Cognitive behavior therapy (CBT), a well-established evidenced-based treatment, helps
patients to identify, and restructure dysfunctional thinking patterns. We propose to test a
brief CBT approach delivered by nurse care managers and supported by a comprehensive mobile
phone CBT skills practice application (app) within primary care. The promising results of our
preliminary studies using a mobile phone app to stimulate real-time CBT skills practice
prompt us to propose a pilot of its use with patients with T2DM with the following aims:

Primary aim: examine feasibility and acceptability of the assessment protocol, and the
recruitment, and retention of study participants.

Secondary aim: 1) collect preliminary data on the effect of the intervention on clinical
outcomes, e.g., self-reported adherence to medication and self-management adherence, e.g.,
diet, exercise; levels of diabetes distress, diabetes medication beliefs, and distal T2DM
outcomes (HbA1c level and body mass index).

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:

1. have a diagnosis of T2DM;

2. have a score of >3 on the Diabetes Distress Scale;

3. be taking at least one oral antihyperglycemic agent (the patient may also be using
injectable antihyperglycemic medications, including insulin);

4. have an HbA1c level of greater than 8 at baseline;

5. be receiving treatment for T2DM in the primary care setting;

6. be aged 30 - 65 years and

7. 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

1. Have received the Brief CBT Training that was given in Phase I of this study;

2. 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:

1. They did not successfully complete the training in Phase I or

2. Are not Nurse Care Managers at UPMC Health Care. -

Exclusion Criteria:

The following are exclusion criteria:

1. major psychiatric disorder and suicidal risk;

2. dementia or disorders with substantial cognitive impairment. -
We found this trial at
1
site
Pittsburgh, Pennsylvania 15261
Principal Investigator: Judith A Callan, PhD, RN
Phone: 412-383-5321
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Pittsburgh, PA
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