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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02081573
• Other study ID #: PRO13050427
• Secondary ID: School of Nursin
• Status: Completed
• Phase: N/A
• First received: March 3, 2014
• Last updated: March 9, 2018
• Start date: January 2013
• Est. completion date: July 2016

Study information

• Verified date: March 2018
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: July 2016
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

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. -

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• Brief CBT
During the course of the twice/month diabetes management phone sessions the nurse care manager will work collaboratively with the patient to identify a dysfunctional belief that may be affecting adherence and could be improved by a brief CBT intervention (5-7 minutes). The care manager will utilize the CBT phone app to identify a CBT intervention that will be most appropriate for the situation. Each intervention is described step by step in the app. The nurse will go through the intervention and when completed will assure the patient's understanding.CBT interventions are geared towards helping the patient identify and restructure thinking that is impairing successful self-management of a chronic disease

Locations

Country	Name	City	State
United States	University of Pittsburgh School of Nursing	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptability Questionnaire.	The acceptability questionnaire measures feasibility and acceptability of the Brief CBT protocol. Adapted from Lewis JR.: IBM Computer Usability Satisfaction Questionnaires: Psychometric Evaluation and Instructions for Use. International Journal of Human-Computer Interaction 1995; 7 (1):67-78. Scale is scored as a mean and ranges from 1-7. In this adaptation, lower scores are better satisfaction.	12 weeks
Secondary	Morisky Questionnaire	Brief scale of adherence to medications. Morisky 5 items was used. Mean score presented. Scale range is from 5-13. Lower score is better adherence. Mean change from baseline to 12 weeks is examined.	12 weeks
Secondary	Diabetes Distress Scale	Levels of diabetes distress per standardized questionnaire will be measured before intervention and after intervention. Change of mean score is reported. Change in score from baseline to post followup. Lower score means less distress. Scale range is from 1-6. Adapted from Fisher, L., Glasgow, R.E., Mullan, J.T., Skaff, M.M., Polonsky, W.H. (2008) Development of a Brief Diabetes Screening Instrument. Annals of Family Medicine; 6:246-252.	12 weeks
Secondary	Medication Beliefs Scale	Change in medication beliefs from before and after intervention. Adapted from Horne, R., Weinman, J., Hankins, M. (1999). The Beliefs About Medicines Questionnaire: The Development and Evaluation of a New Method for Assessing the Cognitive Representation of Medications. Psychology and Health 14: 1-24.	12 weeks
Secondary	HbA1c Level	Change in HbA1c from before to after treatment	12 weeks
Secondary	Body Mass Index	Change in Body Mass Index from before to after treatment	12 weeks