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

NCT02081573 | Completed Results

• 2 other identifiers: PRO13050427School of Nursing eHub pilot
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

Brief CBT; smartphone app; mHealth; diabetes distress; adherence; cognitive behavioral therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Morisky Questionnaire

  12 weeks

• Diabetes Distress Scale

  12 weeks

• Medication Beliefs Scale

  12 weeks

• HbA1c Level

  12 weeks

• Body Mass Index

  12 weeks

Study Arms (1)

Brief CBT

EXPERIMENTAL

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

Behavioral: Brief CBT

Interventions

Brief CBT BEHAVIORAL

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

Also known as: CBT MobileWork

Brief CBT

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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. -

You may not qualify if:

• major psychiatric disorder and suicidal risk;
• dementia or disorders with substantial cognitive impairment. -

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

University of Pittsburgh School of Nursing

Pittsburgh, Pennsylvania, 15261, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Limitations and Caveats

This is a pilot feasibility study with small sample (N=10)

Results Point of Contact

• Title: Judith A. Callan
• Organization: University of Pittsburgh School of Nursing

callanja@pitt.edu

412-383-5321

Study Officials

• Judith A. Callan, PhD, RN

  University of Pittsburgh School of Nursing

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Study Record Dates

• First Submitted: March 3, 2014
• First Posted: March 7, 2014
• Study Start: January 1, 2013
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2016
• Last Updated: March 13, 2018
• Results First Posted: March 13, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)