DiabetesEarly Phase 1ACDCNCT01778751
Advanced Comprehensive Diabetes Care for Veterans With Poorly-Controlled Diabetes
A Early Phase 1 study testing Home Telehealth with Behavioral Education Component in people with Diabetes, run by VA Office of Research and Development at 1 site in United States.
Trial summary
This study will determine whether Home Telehealth-based implementation of an evidence-based intervention targeting Veterans with persistent poorly-controlled diabetes can improve hemoglobin A1c, patient self-management, and comorbid depressive symptoms in this high-risk, high-cost population. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes
- What is being tested?
- Home Telehealth with Behavioral Education Component
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to Dec 2014
- Phase
- Early Phase 1
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Veterans with type 2 diabetes managed for > 1 year at an eligible site (Durham, Raleigh, Greenville, or Morehead City) will be eligible for enrollment.
- We will identify Veterans with PPDM (defined as the presence of at least 2 A1c values of > 9.0% during the past year with no readings of < 9.0% despite ongoing medical care) by reviewing electronic medical records and soliciting referrals from primary physicians.
Who cannot join
- Exclusion criteria will include lack of telephone access or severe hearing/ speech impairment that would limit:
- telephone interaction
- metastatic cancer
- active psychosis documented in medical record
- active alcohol or substance abuse
- diagnosis of dementia
Show all 13Show fewer
- known pregnancy (patients becoming pregnant during the study will be withdrawn and referred to appropriate services)
- documented seizure history
- documented history of severe complications of hypoglycemia (such as coma or seizure)
- documented refusal or inability to perform self-monitoring of blood glucose
- ongoing use of warfarin with prior history of major bleeding event
- Due to challenges with dose adjustment by phone, Veterans on continuous subcutaneous insulin infusion (insulin pumps) will not be eligible for this study.
- Due to challenges with regulations regarding testing supplies pts will need to be taking insulin (a few patients had enrolled prior to this change.).
Trial locations and contacts
1 site in 1 country.
United States1 site
Durham VA Medical Center, Durham, NC
Durham, North Carolina, 27705
About this study
This study will determine whether Home Telehealth-based implementation of an evidence-based intervention targeting Veterans with persistent poorly-controlled diabetes can improve hemoglobin A1c, patient self-management, and comorbid depressive symptoms in this high-risk, high-cost population. If effective, this intervention (Advanced Comprehensive Diabetes Care) offers a feasible, sustainable, and generalizable approach to managing Veterans with persistent poorly-controlled diabetes, which can be implemented using only existing Home Telehealth services.
Read the detailed description
Background: Although efforts by VA providers and researchers have improved diabetes care quality for Veterans, individuals with persistent poorly-controlled diabetes mellitus (type 1 or type 2 diabetes with hemoglobin A1c >9.0% for > 1 year despite receipt of medical care) have proven refractory to these widespread improvements, and remain at high risk for complications and accrued costs. Prior research has illustrated that medication regimen complexity, suboptimal self-care, and comorbid depressive symptoms interact to perpetuate suboptimal control among individuals with PPDM. Current models of clinic-based diabetes care do not meet these Veterans' needs. Without the implementation of care delivery strategies that target this population's unique barriers to improved diabetes control, these Veterans will continue to be left behind by progress in diabetes management throughout VA, and will remain at high risk for complications and high costs. We propose using existing local Home Telehealth services to implement Advanced Comprehensive Diabetes Care, a patient-centered, evidence-based intervention combining medication management, self-care behavior support, and depressive symptom management to Veterans with PPDM.
Objectives: The specific aims of this RRP are to: 1) evaluate the effectiveness of the Advanced Comprehensive Diabetes Care among Veterans with persistent poorly-controlled diabetes; 2) utilize a mixed method formative evaluation to assess our main implementation strategy, the use of existing Home Telehealth services to administer the intervention; and 3) generate data we will use to refine local intervention implementation and inform the development of an SDP proposal evaluating broader implementation of the Advanced Comprehensive Diabetes Care intervention.
Methods: We propose a pilot Effectiveness-Implementation Hybrid trial to study the Advanced Comprehensive Diabetes Care intervention in Veterans with persistent poorly-controlled diabetes. After baseline evaluation, 50 Veterans will be randomly assigned into intervention (n = 25) or control groups (n = 25). Veterans randomized to the intervention will be enrolled in the Home Telehealth program at Durham VAMC and will receive the study intervention (telehealth-based medication management, self-care behavior support, and depressive symptom management) for 6 months. Intervention-group Veterans with no depression on baseline assessment will not initially receive the depressive symptom management component, but will be monitored for new symptoms throughout the study. Veterans randomized to the control arm will receive diabetes educational materials and management per their primary provider. The primary effectiveness outcome for this study will be hemoglobin A1c. Secondary effectiveness outcomes will include measures of diabetes self-care, self-reported medication adherence, and depressive symptoms. This RRP will also include a mixed method formative evaluation to qualitatively and quantitatively assess patient-level, provider-level, and organizational barriers and facilitators influencing intervention implementation. Formative evaluation data will be analyzed during the study to consider whether adjustments to the intervention or its implementation may be indicated, and findings will also be used to inform future implementation efforts.
- Conditions
- Diabetes
- Being tested
- Home Telehealth with Behavioral Education Component
- Keywords
- Self-Management Support, Depression, Home Telehealth
- Medical subject headings
- Diabetes Mellitus, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home Telehealth with Behavioral Education ComponentBehavioural
The primary effectiveness outcome for this study will be hemoglobin A1c. Secondary effectiveness outcomes will include measures of diabetes self-care, self-reported medication adherence, and depressive symptoms.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Veterans will receive diabetes educational materials and management per their primary provider |
| Intervention | Experimental | Veterans randomized to the intervention arm will be enrolled in the HT program, provided with standard telemonitoring equipment by HT nursing staff (current HT practice at DVAMC is use of the Health Buddy 3 device for patients with landline phones and the Cardiocom Interactive Voice Response System for patients with cell phones), and will receive the study intervention for 6 months. Veterans without depressive symptoms on baseline PHQ-9 assessment (PHQ-9 < 10) will not initially be entered into the depressive symptom management component of the intervention, but will be monitored for new symptoms throughout the intervention. Receives: Behavioral: Home Telehealth with Behavioral Education Component |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diabetes Control
Hemoglobin A1c as measured at baseline, 3m, 6m
Measured: Baseline, 3months, 6months
Secondary outcomes (3)
Diabetes Self Care
Self-Care Inventory-revised as measured at baseline, 3 months, 6 months
Measured: Baseline, 3m, 6m
Self-reported Medication Adherence
Change in Self-Reported Medication- Taking Scale as measured at baseline, 3 months, 6 months
Measured: Baseline, 3m, 6m
Depressive Symptoms
Change in Patient Health Questionnaire as measured at Baseline, 3 months, 6 months
Measured: Baseline, 3m, 6m
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2013 (estimated)
- Study startDec 2013
- Primary completionDec 2014
- Study completionDec 2014
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 (1)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies 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
- Early Phase 1
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Matthew J Crowley, MD, Principal investigator, Durham VA Medical Center, Durham, NC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01778751
- Sponsor's protocol ID
- RRP 12-458
- Acronym
- ACDC
- Status last verified
- Dec 2015
- First submitted
- 18 Jan 2013
- Last updated
- 25 Jan 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Crowley MJ, Edelman D, McAndrew AT, Kistler S, Danus S, Webb JA, Zanga J, Sanders LL, Coffman CJ, Jackson GL, Bosworth HB. Practical Telemedicine for Veterans with Persistently Poor Diabetes Control: A Randomized Pilot Trial. Telemed J E Health. 2016 May;22(5):376-84. doi: 10.1089/tmj.2015.0145. Epub 2015 Nov 5.
PubMed 26540163
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advanced Comprehensive Diabetes Care for Veterans With Poorly-Controlled Diabetes
- ClinicalTrials.gov ID
- NCT01778751
- Acronym / sponsor ID
- ACDC / RRP 12-458
- Conditions
- Diabetes
- Keywords
- Self-Management Support, Depression, Home Telehealth
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- Dec 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 29 Jan 2013 (estimated)
- Results
- Posted 25 Jan 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will determine whether Home Telehealth-based implementation of an evidence-based intervention targeting Veterans with persistent poorly-controlled diabetes can improve hemoglobin A1c, patient self-management, and comorbid depressive symptoms in this high-risk, high-cost population. If effective, this intervention (Advanced Comprehensive Diabetes Care) offers a feasible, sustainable, and generalizable approach to managing Veterans with persistent poorly-controlled diabetes, which can be implemented using only existing Home Telehealth services.
Detailed description
Background: Although efforts by VA providers and researchers have improved diabetes care quality for Veterans, individuals with persistent poorly-controlled diabetes mellitus (type 1 or type 2 diabetes with hemoglobin A1c >9.0% for > 1 year despite receipt of medical care) have proven refractory to these widespread improvements, and remain at high risk for complications and accrued costs. Prior research has illustrated that medication regimen complexity, suboptimal self-care, and comorbid depressive symptoms interact to perpetuate suboptimal control among individuals with PPDM. Current models of clinic-based diabetes care do not meet these Veterans' needs. Without the implementation of care delivery strategies that target this population's unique barriers to improved diabetes control, these Veterans will continue to be left behind by progress in diabetes management throughout VA, and will remain at high risk for complications and high costs. We propose using existing local Home Telehealth services to implement Advanced Comprehensive Diabetes Care, a patient-centered, evidence-based intervention combining medication management, self-care behavior support, and depressive symptom management to Veterans with PPDM.
Objectives: The specific aims of this RRP are to: 1) evaluate the effectiveness of the Advanced Comprehensive Diabetes Care among Veterans with persistent poorly-controlled diabetes; 2) utilize a mixed method formative evaluation to assess our main implementation strategy, the use of existing Home Telehealth services to administer the intervention; and 3) generate data we will use to refine local intervention implementation and inform the development of an SDP proposal evaluating broader implementation of the Advanced Comprehensive Diabetes Care intervention.
Methods: We propose a pilot Effectiveness-Implementation Hybrid trial to study the Advanced Comprehensive Diabetes Care intervention in Veterans with persistent poorly-controlled diabetes. After baseline evaluation, 50 Veterans will be randomly assigned into intervention (n = 25) or control groups (n = 25). Veterans randomized to the intervention will be enrolled in the Home Telehealth program at Durham VAMC and will receive the study intervention (telehealth-based medication management, self-care behavior support, and depressive symptom management) for 6 months. Intervention-group Veterans with no depression on baseline assessment will not initially receive the depressive symptom management component, but will be monitored for new symptoms throughout the study. Veterans randomized to the control arm will receive diabetes educational materials and management per their primary provider. The primary effectiveness outcome for this study will be hemoglobin A1c. Secondary effectiveness outcomes will include measures of diabetes self-care, self-reported medication adherence, and depressive symptoms. This RRP will also include a mixed method formative evaluation to qualitatively and quantitatively assess patient-level, provider-level, and organizational barriers and facilitators influencing intervention implementation. Formative evaluation data will be analyzed during the study to consider whether adjustments to the intervention or its implementation may be indicated, and findings will also be used to inform future implementation efforts.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Veterans will receive diabetes educational materials and management per their primary provider |
| Intervention | Experimental | Behavioral: Home Telehealth with Behavioral Education ComponentVeterans randomized to the intervention arm will be enrolled in the HT program, provided with standard telemonitoring equipment by HT nursing staff (current HT practice at DVAMC is use of the Health Buddy 3 device for patients with landline phones and the Cardiocom Interactive Voice Response System for patients with cell phones), and will receive the study intervention for 6 months. Veterans without depressive symptoms on baseline PHQ-9 assessment (PHQ-9 < 10) will not initially be entered into the depressive symptom management component of the intervention, but will be monitored for new symptoms throughout the intervention. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Veterans with type 2 diabetes managed for > 1 year at an eligible site (Durham, Raleigh, Greenville, or Morehead City) will be eligible for enrollment.
- We will identify Veterans with PPDM (defined as the presence of at least 2 A1c values of > 9.0% during the past year with no readings of < 9.0% despite ongoing medical care) by reviewing electronic medical records and soliciting referrals from primary physicians.
Key exclusion criteria (13 listed)
- Exclusion criteria will include lack of telephone access or severe hearing/ speech impairment that would limit:
- Due to challenges with dose adjustment by phone, Veterans on continuous subcutaneous insulin infusion (insulin pumps) will not be eligible for this study.
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 |
|---|---|---|
| Home Telehealth with Behavioral Education ComponentThe primary effectiveness outcome for this study will be hemoglobin A1c. Secondary effectiveness outcomes will include measures of diabetes self-care, self-reported medication adherence, and depressive symptoms. | Behavioural | Intervention |
Primary outcome
Diabetes Control
Time frame: Baseline, 3months, 6months
Hemoglobin A1c as measured at baseline, 3m, 6m
3 secondary outcomes
Diabetes Self Care
Time frame: Baseline, 3m, 6m
Self-reported Medication Adherence
Time frame: Baseline, 3m, 6m
Depressive Symptoms
Time frame: Baseline, 3m, 6m
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26540163Crowley MJ, Edelman D, McAndrew AT, Kistler S, Danus S, Webb JA, Zanga J, Sanders LL, Coffman CJ, Jackson GL, Bosworth HB. Practical Telemedicine for Veterans with Persistently Poor Diabetes Control: A Randomized Pilot Trial. Telemed J E Health. 2016 May;22(5):376-84. doi: 10.1089/tmj.2015.0145. Epub 2015 Nov 5.
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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.
Matthew J Crowley, MD principal investigator
Durham VA Medical Center, Durham, NC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Home Telehealth with Behavioral Education Component in people with Diabetes, 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 2 inclusion and 13 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 25 Jan 2016. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Jan 2016). 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?
Diabetes Control (time frame: Baseline, 3months, 6months). 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 NCT01778751, which also lists 1 linked publication.
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 25 Jan 2016.