Clinical trial NCT02081573: Brief CBT Interventions Delivered by Nurse Care Managers to Improve Type 2 Diabetes Outcomes: Pilot Study
Official title: Brief CBT Interventions Delivered by Nurse Care Managers to Improve Type 2 Diabetes Outcomes: Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Brief CBT
smartphone app
mHealth
diabetes distress
adherence
cognitive behavioral therapy
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2014-03-07
Enrollment: 10
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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).

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:

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. -

Primary outcomes:
measure: Acceptability Questionnaire.
timeFrame: 12 weeks
Secondary outcomes:
measure: Morisky Questionnaire
timeFrame: 12 weeks
measure: Diabetes Distress Scale
timeFrame: 12 weeks
measure: Medication Beliefs Scale
timeFrame: 12 weeks
measure: HbA1c Level
timeFrame: 12 weeks
measure: Body Mass Index
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh School of Nursing
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh School of Nursing
name: Judith A. Callan, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References: