Trial Outcomes & Findings for Brief CBT Interventions Delivered by Nurse Care Managers to Improve Type 2 Diabetes Outcomes: Pilot Study (NCT NCT02081573)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

10 participants

Primary outcome timeframe

12 weeks

Results posted on

2018-03-13

Participant Flow

Participants were recruited from a existing cases of nurse care managers and health coaches who administered the study intervention. Individuals who were interested and had HbA1C higher than 8.0 were screened.

Screened to have mean distress over 2.0 and HbA1C of 8 or above via measurements by our tests.

Participant milestones

Participant milestones
Measure	Brief CBT During the course of the twice/month diabetes management phone sessions, over 3-4 months, 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 interventions.
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Brief CBT n=10 Participants During the course of the twice/month diabetes management phone sessions, over 3-4 months, 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 interventions.
Sex: Female, Male Male	4 Participants n=5 Participants
HbA1C	9.8 percent STANDARD_DEVIATION .9 • n=5 Participants
Age, Continuous	47.7 years n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Distress (Diabetes Distress Scale)	3.52 mean result on scale STANDARD_DEVIATION 1.47 • n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: Mean acceptability of the Brief CBT protocol.

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.

Outcome measures

Outcome measures
Measure	Brief CBT n=10 Participants During the course of the twice/month diabetes management phone sessions, over 3-4 months, 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 interventions.
Acceptability Questionnaire.	2.49 mean of scale items Standard Deviation 1.39

SECONDARY outcome

Timeframe: 12 weeks

Population: Mean change from baseline to 12 weeks.

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.

Outcome measures

Outcome measures
Measure	Brief CBT n=10 Participants During the course of the twice/month diabetes management phone sessions, over 3-4 months, 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 interventions.
Morisky Questionnaire	.10 mean of scale items Standard Deviation 1.73

SECONDARY outcome

Timeframe: 12 weeks

Population: Change in score from baseline to post followup

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.

Outcome measures

Outcome measures
Measure	Brief CBT n=10 Participants During the course of the twice/month diabetes management phone sessions, over 3-4 months, 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 interventions.
Diabetes Distress Scale	-.77 mean of scale items Standard Deviation 1.35

SECONDARY outcome

Timeframe: 12 weeks

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Change in HbA1c from before to after treatment

Outcome measures

Outcome measures
Measure	Brief CBT n=10 Participants During the course of the twice/month diabetes management phone sessions, over 3-4 months, 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 interventions.
HbA1c Level	-.22 percentage of glycosylated hemoglobin Standard Deviation 1.80

SECONDARY outcome

Timeframe: 12 weeks

Population: Change BMI over time.

Change in Body Mass Index from before to after treatment

Outcome measures

Outcome measures
Measure	Brief CBT n=10 Participants During the course of the twice/month diabetes management phone sessions, over 3-4 months, 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 interventions.
Body Mass Index	-1.22 kg/m^2 Standard Deviation 1.39

Adverse Events

Brief CBT

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Judith A. Callan

University of Pittsburgh School of Nursing

Phone: 412-383-5321

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place