Trial Outcomes & Findings for HOPE Pilot for Veterans With Complex Diabetes (NCT NCT01274715)

Results Overview

The full name of the measure is the Patient Health Questionnaire-9. This is a self-reported measure of depressive symptoms. This is a nine item measure with a response for each item between 0-3. Total scores on this measure range from 0-27, with 0 being a minimum indicating no depressive symptoms, and 27 being the maximum number and severity of depressive symptoms. The coaching sessions take place over approximately 3 months -- outcomes are measured at baseline, 3 months and again at 6 months. Change from baseline to 3 months was calculated. Then change from baseline to 6 months was calculated.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

12 participants

Primary outcome timeframe

Baseline, 3 months, and 6 months

Results posted on

2014-05-08

Participant Flow

The recruitment period lasted from January 2011 through July 2011. After patients were screened, recruitment occurred over the phone, where they gave audio consent to participate in the study.

Three participants who gave consent to participate in the study met exclusion criteria at baseline and were removed from the study before being assigned to the intervention.

Participant milestones

Participant milestones
Measure	Behavioral Health Coaching Behavioral health coaching consisting of goal-setting, action planning, behavioral activation, and cognitive therapy is delivered by telephone over approximately 3 months.
Overall Study STARTED	12
Overall Study Screened Out at Baseline	3
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Behavioral Health Coaching Behavioral health coaching consisting of goal-setting, action planning, behavioral activation, and cognitive therapy is delivered by telephone over approximately 3 months.
Overall Study Lost to Follow-up	1
Overall Study After consent, met exclusion criteria.	1

Baseline Characteristics

HOPE Pilot for Veterans With Complex Diabetes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Behavioral Health Coaching n=12 Participants Behavioral health coaching consisting of goal-setting, action planning, behavioral activation, and cognitive therapy is delivered by telephone over approximately 3 months.
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=93 Participants
Age, Categorical >=65 years	2 Participants n=93 Participants
Age, Continuous	61.4 years STANDARD_DEVIATION 5.71 • n=93 Participants
Sex: Female, Male Female	3 Participants n=93 Participants
Sex: Female, Male Male	9 Participants n=93 Participants
Region of Enrollment United States	12 participants n=93 Participants

PRIMARY outcome

Timeframe: Baseline, 3 months, and 6 months

The full name of the measure is the Patient Health Questionnaire-9. This is a self-reported measure of depressive symptoms. This is a nine item measure with a response for each item between 0-3. Total scores on this measure range from 0-27, with 0 being a minimum indicating no depressive symptoms, and 27 being the maximum number and severity of depressive symptoms. The coaching sessions take place over approximately 3 months -- outcomes are measured at baseline, 3 months and again at 6 months. Change from baseline to 3 months was calculated. Then change from baseline to 6 months was calculated.

Outcome measures

Outcome measures
Measure	Behavioral Health Coaching n=8 Participants Behavioral health coaching consisting of goal-setting, action planning, behavioral activation, and cognitive therapy is delivered by telephone over approximately 3 months.
Change in PHQ-9 (Patient Health Questionnaire-9)Scores Change from baseline to 3-month, M (SD)	5.14 scores on a scale Standard Deviation 2.27
Change in PHQ-9 (Patient Health Questionnaire-9)Scores Change from baseline to 6-month, M (SD)	7.03 scores on a scale Standard Deviation 4.43

PRIMARY outcome

Timeframe: baseline, 3 months, and 6 months

Value of Hemoglobin A1C reduction post-intervention. The coaching sessions take place over approximately 3 months -- outcomes are measured at baseline, 3 months and again at 6 months. Change from baseline to 3 months was calculated. Then change from baseline to 6 months was calculated.

Outcome measures

Outcome measures
Measure	Behavioral Health Coaching n=8 Participants Behavioral health coaching consisting of goal-setting, action planning, behavioral activation, and cognitive therapy is delivered by telephone over approximately 3 months.
Change in Hemoglobin A1C Change from baseline to 3 months	1.13 percentage of glycated hemoglobin Standard Deviation 1.7
Change in Hemoglobin A1C Change from baseline to 6 months	0.84 percentage of glycated hemoglobin Standard Deviation 1.62

Adverse Events

Behavioral Health Coaching

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

Aanand Naik, MD

Michael DeBakey VAMC

Phone: 713-794-8541

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place