NCT01274715

Brief Summary

The purpose of this study is to determine if behavioral health coaching for rural veterans with diabetes and depression will improve self-management behaviors and lead to improvement in diabetes care outcomes (e.g., HA1C) and improvement in reported depressive symptoms.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable diabetes

Timeline
Completed

Started Jan 2011

Shorter than P25 for not_applicable diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

January 10, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 11, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
2.9 years until next milestone

Results Posted

Study results publicly available

May 8, 2014

Completed
Last Updated

May 8, 2014

Status Verified

April 1, 2014

Enrollment Period

6 months

First QC Date

January 10, 2011

Results QC Date

October 25, 2012

Last Update Submit

April 7, 2014

Conditions

DiabetesDepression

Keywords

Behavioral health coachingDiabetesEmotional health

Outcome Measures

Primary Outcomes (2)

  • Change in PHQ-9 (Patient Health Questionnaire-9)Scores

    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.

    Baseline, 3 months, and 6 months

  • Change in Hemoglobin A1C

    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.

    baseline, 3 months, and 6 months

Study Arms (1)

Behavioral Health Coaching arm

EXPERIMENTAL

This is a single-arm, pilot study of a health behavior coaching intervention to consist of 12 sessions of coaching over a 3 month period. There is no control arm for this pilot study.

Behavioral: Behavioral Health Coaching

Interventions

Behavioral Health CoachingBEHAVIORAL

Behavioral health coaching consisting of goal-setting, action planning, behavioral activation, and cognitive therapy is delivered by telephone over approximately 3 months.

Behavioral Health Coaching arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of type 2 diabetes and Primary Care Physician intent to treat
  • Clinically significant symptoms of depression per self-report
  • HA1C average of 7.5 or greater in past 12 months AND no HA1C \< 7.0 in past 12 months.

You may not qualify if:

  • Factors that render a telephone-based behavioral activation intervention inappropriate
  • Significant cognitive impairment
  • Meet criteria of bipolar, psychotic or substance abuse disorder
  • Serious medical issues; e.g., terminal cancer
  • Reports severe depression or suicidal ideation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MEDVAMC

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • Naik AD, White CD, Robertson SM, Armento ME, Lawrence B, Stelljes LA, Cully JA. Behavioral health coaching for rural-living older adults with diabetes and depression: an open pilot of the HOPE Study. BMC Geriatr. 2012 Jul 24;12:37. doi: 10.1186/1471-2318-12-37.

    PMID: 22828177RESULT

MeSH Terms

Conditions

Diabetes MellitusDepressionPsychological Well-Being

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehavioral SymptomsBehaviorPersonal Satisfaction

Limitations and Caveats

A very small sample was collected, and there was not a control group to compare to our intervention group.

Results Point of Contact

Title
Aanand Naik, MD
Organization
Michael DeBakey VAMC
anaik@bcm.edu
713-794-8541

Study Officials

  • Aanand D Naik, MD

    Michael E. DeBakey VA Medical Center

    PRINCIPAL INVESTIGATOR

  • Jeffrey A Cully, PhD

    Michael E. DeBakey VA Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine

Study Record Dates

First Submitted

January 10, 2011

First Posted

January 11, 2011

Study Start

January 1, 2011

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

May 8, 2014

Results First Posted

May 8, 2014

Record last verified: 2014-04

Locations

US(1)