Diabetes MellitusNCT01572389
Behavioral Activation Therapy for Rural Veterans With Diabetes and Depression
A study testing Healthy Outcomes through Patient Empowerment (HOPE) in people with Diabetes Mellitus and Depression, run by VA Office of Research and Development at 1 site in United States.
Trial summary
This clinical trial will compare the effectiveness of the Healthy Outcomes through Patient Empowerment (HOPE) intervention to enhanced usual care (EUC) for diabetes and depression at 6 and 12 month follow-up. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Depression
- What is being tested?
- Healthy Outcomes through Patient Empowerment (HOPE)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2012to 30 Sep 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Veterans with comorbid diabetes and depressive symptoms receiving primary care services at VA CBOCs throughout Southeast Texas
- as well as MEDVAMC patients living >20 miles from the hospital who face similar distance related treatment barriers
- Participants must have:
- a diagnosis of diabetes mellitus
- an average HbA1c level >7.5% in the prior 6 months
- clinically significant symptoms of depression
- Verification of diabetes mellitus diagnoses will be based on data collected from the VA data warehouse.
- To verify that participants meet the depression criteria, the investigators will use participant self-report of clinically significant depressive symptoms according to the PHQ-9, where a score of greater than/equal to 10 on the PHQ-9 will signify a clinically meaningful symptom burden.
Who cannot join
- The investigators will exclude potential participants only for clinical factors that would render a telephone-based behavioral activation intervention inappropriate.
- Specific exclusion criteria are:
- lack of regular access to a telephone
- significant cognitive impairment (three or more errors) on an established six-item screening exam
- meeting criteria for bipolar, psychotic, or substance-abuse disorders
- presence of uncorrected hearing or vision impairment
Show all 11Show fewer
- their medical chart recommends not titrating therapy due to prior history of significant hypoglycemic events
- they live within 20 miles of the MEDVAMC.
- Patients will be secondarily excluded if their HbA1C level falls below 7.5% at baseline assessment, or if they report suicidal ideation on the PHQ-9 at baseline assessment.
- Patients receiving mental health services at the time of study recruitment will not be excluded.
- All mental health treatments and health service-use characteristics will be included in study analyses as covariates.
Trial locations and contacts
1 site in 1 country.
United States1 site
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, 77030
About this study
This clinical trial will compare the effectiveness of the Healthy Outcomes through Patient Empowerment (HOPE) intervention to enhanced usual care (EUC) for diabetes and depression at 6 and 12 month follow-up. The proposed study is a randomized controlled trial enrolling 242 largely rural Veterans with uncontrolled diabetes and clinically-significant depressive symptoms. Both groups will receive screening, education, and notification of clinical findings along with follow-up in usual primary care. HOPE participants will also receive behavioral coaching telephone sessions over a six month period. Patients in the control group will be screened, and providers will be notified of high risk patients' status and need for intervention. Both groups will receive only usual primary care during the subsequent 6 month maintenance period. Study measurements using self-report questionnaires will also be collected at baseline, 6 and 12 months follow-up. The investigators will also conduct chart reviews to evaluate usual care blood tests for diabetes control. Changes in measurements from baseline will be compared between groups. This intervention will reach Veterans in rural setting where community-based primary care is needed, especially care that blends treatment strategies for physical and emotional health.
Read the detailed description
Project Background: The co-occurrence of diabetes and depressive symptoms is highly prevalent and has dramatic consequences on the quality of life and health of affected patients. Due to the complex interrelation between these conditions, patients often experience both psychological and physiological difficulties. Furthermore, Veterans with diabetes and depressive symptoms in rural settings have limited access to care. Interventions that reach Veterans in rural / community-based primary care are needed, especially those that blend treatment strategies for physical and emotional health.
Project Objectives: Specific (Primary) Aim (1): Compare the effectiveness of the Healthy Outcomes through Patient Empowerment (HOPE) intervention to enhanced usual care (EUC) at 6 and 12 month follow-up.
Hypothesis 1a: After 6 months (active treatment phase), HOPE will produce greater improvements in diabetes control (measured by hemoglobin A1c levels) and depression (measured by PHQ-9 scores) than will EUC.
Hypothesis 1b: At 12 months (6-month active phase plus 6-month maintenance phase), HOPE participants will continue to evidence significant greater improvements in HbA1c and PHQ-9 compared with EUC participants.
Exploratory Specific Aim (2): To examine the role of moderators and mediators on intervention effectiveness Exploratory Aim 2a. To evaluate factors that mediate or moderate effectiveness at 6 and 12 months for all enrolled patients (regardless of intervention group assignment). Potential mediating and moderating variables include patient-level (clinical factors-diabetes distress and self-efficacy and sociodemographics) and facility-level factors (availability of medical and mental health services by clinical site).
Exploratory Aim 2b. To evaluate factors that mediate or moderate effectiveness at 6 and 12 months for patients enrolled in the HOPE intervention arm. Intervention factors include adherence (e.g. session attendance), fidelity (ratings of coach effectiveness), and treatment implementation (e.g., goal setting quality and self-management behaviors) as well as any significant predictors obtained from Aim 1a.
Exploratory Specific Aim (3): Evaluate the potential for embedding the HOPE intervention processes within a VA CBOC using the REAIM framework for evaluating effectiveness of behavioral interventions.
Exploratory Aim 3a - Reach. Compare clinical and demographic characteristics of enrolled study participants with the characteristics of all potentially eligible patients at each CBOC.
Exploratory Aim 3b - Adoption. Qualitatively elicit clinicians' perceptions of behavioral coaches, patients' use of action plans, and responses to coaches' recommendations in preparation for future implementation
Project Methods: The proposed study is a randomized controlled trial enrolling 242 largely rural Veterans with uncontrolled diabetes and clinically-significant depressive symptoms. Both groups will receive screening, education, and notification of clinical findings along with follow-up in usual primary care. HOPE participants will also receive 6 behavioral coaching telephone sessions and 3 booster sessions over a six month period. Coaches will use a standardized, theory-based process for conducting the sessions with the aim of creating patient-centered and articulated goals and behavioral action plans. Participants' primary care providers will be notified about session discussions and the resultant goals and action plans. Both groups will receive only usual primary care during the subsequent 6 months maintenance period. Hemoglobin A1c and PHQ-9 measurements along with self-report questionnaires will also be collected at baseline, 6 and 12 months follow-up. Changes in measurements from baseline will be compared between groups. Analytic evaluations of intervention mediators/moderators and implementation will also be conducted at 6 and 12 months follow-up.
- Conditions
- Diabetes Mellitus, Depression
- Being tested
- Healthy Outcomes through Patient Empowerment (HOPE), Enhanced Usual Care
- Keywords
- Diabetes Mellitus, Depression, Affective Symptoms, Self Care, Telemedicine, Psychotherapy
- Medical subject headings
- Diabetes Mellitus, Depression, Affective Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy Outcomes through Patient Empowerment (HOPE)Behavioural
HOPE participants will receive 6 behavioral coaching telephone sessions and 3 booster sessions over a six month period followed by usual primary care during the subsequent 6 months maintenance period.
Enhanced Usual CareBehavioural
All participants receive usual VA primary care plus a dedicated screening for diabetes control and clinically significant depressive symptoms. Patients and primary care providers are notified of these results and given recommendations for usual care.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: HOPE | Experimental | The Healthy Outcomes through Patient Empowerment (HOPE) intervention group is the intervention arm which will employ behavioral health coaching telephone sessions. Tele-coaching is a theoretically grounded, structured processes guided by intervention manuals. Receives: Behavioral: Healthy Outcomes through Patient Empowerment (HOPE) |
| Arm 2: EUC | Active comparator | The Enhanced Usual Care (EUC) group will serve as a concurrent control group to compare to the intervention arm of the study. Participants are screened for diabetes self-management behaviors and control and for active depressive and anxiety symptoms. Primary care providers are alerted of the patients' status and given decision support to enhance care for these uncontrolled conditions. Receives: Behavioral: Enhanced Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hemoglobin A1C
Measures of Hemoglobin A1C will be taken to assess average blood glucose levels throughout the study as an indicator of diabetes control. Hemoglobin A1C is a blood test taken to assess average blood glucose levels in the body. Normal range of A1C level is below 5.7. Eligible participants had an A1C of 7.5 or higher. The higher the A1C the more a person's diabetes is uncontrolled.
Measured: Hemoglobin A1C levels will be measured at baseline, 6-, and 12- months.
Change in Patient Health Questionnaires-9 During Intervention
The Patient Health Questionnaires-9 assesses depressive symptoms during the course of the intervention. The PHQ-9 ranges in score from 0 - 27; where higher numbers represent increase levels of depression. Scores from 5 - 9 represent "minimal symptoms" of depression; 10 - 14 represent "minor depression", dysthymia, or major depression - mild; 15 - 19 represent "major depression, moderately severe"; and scores of 20 and above is considered "major depression, severe." Participants with that scored a 10 or above were eligible for the study.
Measured: PHQ-9 will be assessed at baseline, 6-, and 12- months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2012 (estimated)
- Study start1 Nov 2012
- Primary completion24 Jun 2016
- Study completion30 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Aanand D Naik, MD BA, Principal investigator, Michael E. DeBakey VA Medical Center, Houston, TXJeffrey Cully, PhD MEd, Principal investigator, Michael E. DeBakey VA Medical Center, Houston, TX
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01572389
- Sponsor's protocol ID
- IIR 10-135
- Status last verified
- Jun 2017
- First submitted
- 7 Mar 2012
- Last updated
- 1 Nov 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Martin CE, Renn BN, Winderman KE, Hundt N, Petersen NJ, Naik AD, Cully JA. Classifying diabetes-burden: A factor analysis of the Problem Areas in Diabetes Scale. J Health Psychol. 2018 May;23(6):882-888. doi: 10.1177/1359105316678667. Epub 2016 Nov 21.
PubMed 27872390Tinetti ME, Naik AD, Dodson JA. Moving From Disease-Centered to Patient Goals-Directed Care for Patients With Multiple Chronic Conditions: Patient Value-Based Care. JAMA Cardiol. 2016 Apr 1;1(1):9-10. doi: 10.1001/jamacardio.2015.0248. No abstract available.
PubMed 27437646Naik AD, Lawrence B, Kiefer L, Ramos K, Utech A, Masozera N, Rao R, Petersen NJ, Kunik ME, Cully JA. Building a primary care/research partnership: lessons learned from a telehealth intervention for diabetes and depression. Fam Pract. 2015 Apr;32(2):216-23. doi: 10.1093/fampra/cmu084. Epub 2014 Dec 31.
PubMed 25552674Cully JA, Breland JY, Robertson S, Utech AE, Hundt N, Kunik ME, Petersen NJ, Masozera N, Rao R, Naik AD. Behavioral health coaching for rural veterans with diabetes and depression: a patient randomized effectiveness implementation trial. BMC Health Serv Res. 2014 Apr 28;14:191. doi: 10.1186/1472-6963-14-191.
PubMed 24774351Naik 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.
PubMed 22828177Vaughan EM, Cully JA, Petersen NJ, Hundt NE, Kunik ME, Zeno DD, Naik AD. Testing the Impact of a Collaborative, Goal-Setting, and Behavioral Telehealth Intervention on Diabetes Distress: A Randomized Clinical Trial. Telemed J E Health. 2022 Jan;28(1):84-92. doi: 10.1089/tmj.2020.0533. Epub 2021 Mar 15.
PubMed 33728989Naik AD, Hundt NE, Vaughan EM, Petersen NJ, Zeno D, Kunik ME, Cully JA. Effect of Telephone-Delivered Collaborative Goal Setting and Behavioral Activation vs Enhanced Usual Care for Depression Among Adults With Uncontrolled Diabetes: A Randomized Clinical Trial. JAMA Netw Open. 2019 Aug 2;2(8):e198634. doi: 10.1001/jamanetworkopen.2019.8634.
PubMed 31390035
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Activation Therapy for Rural Veterans With Diabetes and Depression
- ClinicalTrials.gov ID
- NCT01572389
- Acronym / sponsor ID
- IIR 10-135
- Conditions
- Diabetes Mellitus, Depression
- Keywords
- Diabetes Mellitus, Depression, Affective Symptoms, Self Care, Telemedicine, Psychotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Nov 2012 (actual)
- Primary completion
- 24 Jun 2016 (actual)
- Study completion
- 30 Sep 2016 (actual)
- First posted
- 6 Apr 2012 (estimated)
- Results
- Posted 1 Nov 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial will compare the effectiveness of the Healthy Outcomes through Patient Empowerment (HOPE) intervention to enhanced usual care (EUC) for diabetes and depression at 6 and 12 month follow-up. The proposed study is a randomized controlled trial enrolling 242 largely rural Veterans with uncontrolled diabetes and clinically-significant depressive symptoms. Both groups will receive screening, education, and notification of clinical findings along with follow-up in usual primary care. HOPE participants will also receive behavioral coaching telephone sessions over a six month period. Patients in the control group will be screened, and providers will be notified of high risk patients' status and need for intervention. Both groups will receive only usual primary care during the subsequent 6 month maintenance period. Study measurements using self-report questionnaires will also be collected at baseline, 6 and 12 months follow-up. The investigators will also conduct chart reviews to evaluate usual care blood tests for diabetes control. Changes in measurements from baseline will be compared between groups. This intervention will reach Veterans in rural setting where community-based primary care is needed, especially care that blends treatment strategies for physical and emotional health.
Detailed description
Project Background: The co-occurrence of diabetes and depressive symptoms is highly prevalent and has dramatic consequences on the quality of life and health of affected patients. Due to the complex interrelation between these conditions, patients often experience both psychological and physiological difficulties. Furthermore, Veterans with diabetes and depressive symptoms in rural settings have limited access to care. Interventions that reach Veterans in rural / community-based primary care are needed, especially those that blend treatment strategies for physical and emotional health.
Project Objectives: Specific (Primary) Aim (1): Compare the effectiveness of the Healthy Outcomes through Patient Empowerment (HOPE) intervention to enhanced usual care (EUC) at 6 and 12 month follow-up.
Hypothesis 1a: After 6 months (active treatment phase), HOPE will produce greater improvements in diabetes control (measured by hemoglobin A1c levels) and depression (measured by PHQ-9 scores) than will EUC.
Hypothesis 1b: At 12 months (6-month active phase plus 6-month maintenance phase), HOPE participants will continue to evidence significant greater improvements in HbA1c and PHQ-9 compared with EUC participants.
Exploratory Specific Aim (2): To examine the role of moderators and mediators on intervention effectiveness Exploratory Aim 2a. To evaluate factors that mediate or moderate effectiveness at 6 and 12 months for all enrolled patients (regardless of intervention group assignment). Potential mediating and moderating variables include patient-level (clinical factors-diabetes distress and self-efficacy and sociodemographics) and facility-level factors (availability of medical and mental health services by clinical site).
Exploratory Aim 2b. To evaluate factors that mediate or moderate effectiveness at 6 and 12 months for patients enrolled in the HOPE intervention arm. Intervention factors include adherence (e.g. session attendance), fidelity (ratings of coach effectiveness), and treatment implementation (e.g., goal setting quality and self-management behaviors) as well as any significant predictors obtained from Aim 1a.
Exploratory Specific Aim (3): Evaluate the potential for embedding the HOPE intervention processes within a VA CBOC using the REAIM framework for evaluating effectiveness of behavioral interventions.
Exploratory Aim 3a - Reach. Compare clinical and demographic characteristics of enrolled study participants with the characteristics of all potentially eligible patients at each CBOC.
Exploratory Aim 3b - Adoption. Qualitatively elicit clinicians' perceptions of behavioral coaches, patients' use of action plans, and responses to coaches' recommendations in preparation for future implementation
Project Methods: The proposed study is a randomized controlled trial enrolling 242 largely rural Veterans with uncontrolled diabetes and clinically-significant depressive symptoms. Both groups will receive screening, education, and notification of clinical findings along with follow-up in usual primary care. HOPE participants will also receive 6 behavioral coaching telephone sessions and 3 booster sessions over a six month period. Coaches will use a standardized, theory-based process for conducting the sessions with the aim of creating patient-centered and articulated goals and behavioral action plans. Participants' primary care providers will be notified about session discussions and the resultant goals and action plans. Both groups will receive only usual primary care during the subsequent 6 months maintenance period. Hemoglobin A1c and PHQ-9 measurements along with self-report questionnaires will also be collected at baseline, 6 and 12 months follow-up. Changes in measurements from baseline will be compared between groups. Analytic evaluations of intervention mediators/moderators and implementation will also be conducted at 6 and 12 months follow-up.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: HOPE | Experimental | Behavioral: Healthy Outcomes through Patient Empowerment (HOPE)The Healthy Outcomes through Patient Empowerment (HOPE) intervention group is the intervention arm which will employ behavioral health coaching telephone sessions. Tele-coaching is a theoretically grounded, structured processes guided by intervention manuals. |
| Arm 2: EUC | Active comparator | Behavioral: Enhanced Usual CareThe Enhanced Usual Care (EUC) group will serve as a concurrent control group to compare to the intervention arm of the study. Participants are screened for diabetes self-management behaviors and control and for active depressive and anxiety symptoms. Primary care providers are alerted of the patients' status and given decision support to enhance care for these uncontrolled conditions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Veterans with comorbid diabetes and depressive symptoms receiving primary care services at VA CBOCs throughout Southeast Texas
- as well as MEDVAMC patients living >20 miles from the hospital who face similar distance related treatment barriers
- a diagnosis of diabetes mellitus
- an average HbA1c level >7.5% in the prior 6 months
- clinically significant symptoms of depression
Key exclusion criteria (11 listed)
- The investigators will exclude potential participants only for clinical factors that would render a telephone-based behavioral activation intervention inappropriate.
- Specific exclusion criteria are:
- Patients will be secondarily excluded if their HbA1C level falls below 7.5% at baseline assessment, or if they report suicidal ideation on the PHQ-9 at baseline assessment.
- Patients receiving mental health services at the time of study recruitment will not be excluded.
- All mental health treatments and health service-use characteristics will be included in study analyses as covariates.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Healthy Outcomes through Patient Empowerment (HOPE)HOPE participants will receive 6 behavioral coaching telephone sessions and 3 booster sessions over a six month period followed by usual primary care during the subsequent 6 months maintenance period. | Behavioural | Arm 1: HOPE |
| Enhanced Usual CareAll participants receive usual VA primary care plus a dedicated screening for diabetes control and clinically significant depressive symptoms. Patients and primary care providers are notified of these results and given recommendations for usual care. | Behavioural | Arm 2: EUC |
Primary outcome
Change in Hemoglobin A1C
Time frame: Hemoglobin A1C levels will be measured at baseline, 6-, and 12- months.
Measures of Hemoglobin A1C will be taken to assess average blood glucose levels throughout the study as an indicator of diabetes control. Hemoglobin A1C is a blood test taken to assess average blood glucose levels in the body. Normal range of A1C level is below 5.7. Eligible participants had an A1C of 7.5 or higher. The higher the A1C the more a person's diabetes is uncontrolled.
Change in Patient Health Questionnaires-9 During Intervention
Time frame: PHQ-9 will be assessed at baseline, 6-, and 12- months.
The Patient Health Questionnaires-9 assesses depressive symptoms during the course of the intervention. The PHQ-9 ranges in score from 0 - 27; where higher numbers represent increase levels of depression. Scores from 5 - 9 represent "minimal symptoms" of depression; 10 - 14 represent "minor depression", dysthymia, or major depression - mild; 15 - 19 represent "major depression, moderately severe"; and scores of 20 and above is considered "major depression, severe." Participants with that scored a 10 or above were eligible for the study.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 27872390Martin CE, Renn BN, Winderman KE, Hundt N, Petersen NJ, Naik AD, Cully JA. Classifying diabetes-burden: A factor analysis of the Problem Areas in Diabetes Scale. J Health Psychol. 2018 May;23(6):882-888. doi: 10.1177/1359105316678667. Epub 2016 Nov 21.
- Results publication: PubMed 27437646Tinetti ME, Naik AD, Dodson JA. Moving From Disease-Centered to Patient Goals-Directed Care for Patients With Multiple Chronic Conditions: Patient Value-Based Care. JAMA Cardiol. 2016 Apr 1;1(1):9-10. doi: 10.1001/jamacardio.2015.0248. No abstract available.
- Results publication: PubMed 25552674Naik AD, Lawrence B, Kiefer L, Ramos K, Utech A, Masozera N, Rao R, Petersen NJ, Kunik ME, Cully JA. Building a primary care/research partnership: lessons learned from a telehealth intervention for diabetes and depression. Fam Pract. 2015 Apr;32(2):216-23. doi: 10.1093/fampra/cmu084. Epub 2014 Dec 31.
- Results publication: PubMed 24774351Cully JA, Breland JY, Robertson S, Utech AE, Hundt N, Kunik ME, Petersen NJ, Masozera N, Rao R, Naik AD. Behavioral health coaching for rural veterans with diabetes and depression: a patient randomized effectiveness implementation trial. BMC Health Serv Res. 2014 Apr 28;14:191. doi: 10.1186/1472-6963-14-191.
- Results publication: PubMed 22828177Naik 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.
- Derived from this study: PubMed 33728989Vaughan EM, Cully JA, Petersen NJ, Hundt NE, Kunik ME, Zeno DD, Naik AD. Testing the Impact of a Collaborative, Goal-Setting, and Behavioral Telehealth Intervention on Diabetes Distress: A Randomized Clinical Trial. Telemed J E Health. 2022 Jan;28(1):84-92. doi: 10.1089/tmj.2020.0533. Epub 2021 Mar 15.
- Derived from this study: PubMed 31390035Naik AD, Hundt NE, Vaughan EM, Petersen NJ, Zeno D, Kunik ME, Cully JA. Effect of Telephone-Delivered Collaborative Goal Setting and Behavioral Activation vs Enhanced Usual Care for Depression Among Adults With Uncontrolled Diabetes: A Randomized Clinical Trial. JAMA Netw Open. 2019 Aug 2;2(8):e198634. doi: 10.1001/jamanetworkopen.2019.8634.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aanand D Naik, MD BA principal investigator
Michael E. DeBakey VA Medical Center, Houston, TX
Jeffrey Cully, PhD MEd principal investigator
Michael E. DeBakey VA Medical Center, Houston, TX
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy Outcomes through Patient Empowerment (HOPE) in people with Diabetes Mellitus and Depression, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Nov 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hemoglobin A1C (time frame: Hemoglobin A1C levels will be measured at baseline, 6-, and 12- months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01572389, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2017.