DiabetesVA-TECNCT01855399
Technologically Enhanced Coaching: A Program to Improve Diabetes Outcomes
A study testing Peer Coaching and Decision Aid in people with Diabetes, run by VA Office of Research and Development at 2 sites in United States.
Trial summary
Peer support programs have been demonstrated to improve glycemic control among Veterans with poor control. This program will expand on this success by putting innovative tools in the hands of Veteran diabetes patients. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Diabetes
- What is being tested?
- Peer Coaching and Decision Aid
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 290 participants
- Where
- 2 sitesUnited States
- Study dates
- 9 Sep 2014to 29 Sep 2017
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- one hospitalization with a diabetes-related ICD-9 code
- two outpatient visits with a diabetes-related ICD-9 code
- at least one prescription for a glucose control medication (insulin or oral agents) or monitoring supplies.
- [70] Potential participants must also have their most recent A1c in the prior 6 months be at least 8.0% if age < 70 or at least 8.5% if age 70+).
Who cannot join
- Using ICD-9 diagnostic codes, the investigators will exclude patients if they have an active substance abuse disorder or serious psychiatric illness:
- PTSD
- bipolar disorder
- dementia
- schizophrenia
- or personality disorders
- We will then send names of the patients to their primary care providers to identify any patients who they do not recommend inviting to participate in the program.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, 48105
John D. Dingell VA Medical Center, Detroit, MI
Detroit, Michigan, 48201
About this study
Official title: Technologically Enhanced Coaching (TEC):A Program for Improving Diabetes Outcomes
Peer support programs have been demonstrated to improve glycemic control among Veterans with poor control. This program will expand on this success by putting innovative tools in the hands of Veteran diabetes patients. Veteran coaches who have demonstrated effective control of their own diabetes will be trained to use communication skills to guide their peers through a diabetes education and decision aid. This tool, which is an iPad application, draws the patient in by showing them their personal risk and medication information derived from baseline labs and self-reported survey data. The tool encourages interaction by providing choices of materials to view, using audio-visual elements and incorporating a goal-setting process for developing self-management action steps and questions to discuss with their doctor at their next clinic visit. Ongoing weekly contact between the Veterans is supported by a confidential phone system.
Read the detailed description
Peer mentoring and support models have been found in two recent VA Randomized Controlled Trials (RCTs) to be more effective than usual care, financial incentives, and usual nurse care management to improve glycemic control in high-risk Veteran patients with poor glycemic control. Such models are important complements to provision of care by formal health care providers as they provide sustained, flexible between-visit support. Peer supporters and coaches can be trained in effective behavioral approaches to support other Veterans' self-management behaviors. Such supporters, however, necessarily lack the content expertise to help Veterans make informed treatment decisions and set health goals with their health care providers. Accordingly, in a recent study the investigators developed and tested a tailored, interactive computer-based tool with diabetes and medication information embedded in the tool's software that peer coaches and other outreach workers can employ to facilitate discussions with patients. Such tailored, interactive tools have been found to be more effective than generic educational and decision support tools in improving clinical and patient-centered outcomes. Moreover, these tools could enhance the sustainability and effectiveness of coaching programs to better prepare patients to set self-management goals and action plans, and to discuss treatment options with their health care providers. With VA support and input from Veterans, the investigators adapted the tailored, interactive computer-based tool for use with and by Veterans with diabetes. The investigators now propose to incorporate this tool into a peer mentor-led diabetes self-management coaching program among predominantly African American Veterans with poor glycemic control at the Detroit VA, a VA health system with high rates of poor risk factor control among diabetes patients. The investigators propose to evaluate this Technology-Enhanced Coaching (TEC) program. Specifically, the investigators propose to:
Aim 1: Test the effectiveness of a technology-enhanced peer coaching (TEC) program in improving glucose control relative to peer coaching without technology enhancement; and, also test the effectiveness of peer support compared to observed usual care. For the "usual care" observed group, the investigators will use electronic health record data to measure A1c levels.
Aim 2: Assess the impact of the intervention on key patient-centered outcomes, including patients' satisfaction and involvement with care, perceived social support, diabetes-specific quality of life, and medication adherence.
Aim 3: Identify patient characteristics associated with engagement in the intervention and mediators and moderators of the intervention's impact on patient outcomes.
In summary, the TEC program builds on the demonstrated strengths of peer support models and of tailored, interactive decision support tools in improving diabetes self-management and outcomes. This study will test incorporation of tailored interactive educational tools into a peer coaching model found in prior VA RCTs to be effective in improving diabetes outcomes.
The tools tested in the proposed intervention will be disseminated for use in other VA sites through a tool kit with training and support materials. Because the intervention addresses barriers to disease management for chronically ill patients, physicians, and case managers, the study may have broader impact on management practices for other chronic illnesses.
- Conditions
- Diabetes
- Being tested
- Peer Coaching, Decision Aid
- Keywords
- Peer Support, Self Management, Health Disparities
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer CoachingBehavioural
All participants will be assigned to a peer coach, who is a Detroit VA diabetes patient who previously had poor glycemic control but is currently in good control. Participants will receive information on their lab and blood pressure values and will be scheduled for an initial visit with their coach. The coach will then help them list questions and concerns they wish to discuss with their health care provider, practice raising their questions and concerns, and develop an action plan to address barriers to self-management they have identified. During the next six months, coaches will call their assigned peers once a week to provide support for their action steps.
Decision AidBehavioural
Also called TEC
The iDecide tool is designed to present key tailored, evidence-based information on diabetes and diabetes treatments. Importantly for a peer support intervention, all content information will be provided through the tool, with the role of the peer mentor being to assist the participant to go through the program and participate in helping the patient formulate questions and concerns to discuss with their health care provider, to set their own behavioral goals and action steps, and to help the participant practice raising the issues they plan to discuss with their health care provider.
| Study group | Role | What they receive |
|---|---|---|
| Peer Coaching + Decision Aid | Experimental | All participants will be assigned to one of up to 87 peer coaches, who also are Detroit VA diabetes patients who previously had poor glycemic control but are currently in good control. After their baseline assessment, participants in both arms will receive information on their lab and blood pressure values and will be randomized to one of the two study arms. Participants in the TEC arm will be scheduled for an initial visit with their coach to review the decision aid, which has incorporated their personal baseline data. Receives: Behavioral: Peer Coaching; Behavioral: Decision Aid |
| Peer Coaching Alone | Active comparator | Participants randomized to the 'print materials' group will be scheduled for an initial visit with their coach. The coach will then help them list questions and concerns they wish to discuss with their health care provider, practice raising their questions and concerns and develop an action plan to address barriers to self-management they have identified. During the next six months coaches in both arms will call their assigned peers once a week to provide support for their action steps. Receives: Behavioral: Peer Coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Glycosylated Hemoglobin
Percent glycosylated hemoglobin is measured at baseline, 6 months, and 12 months to test the effectiveness of a technology-enhanced peer coaching (TEC) program in improving glucose control relative to peer support alone.
Measured: 6 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2013 (estimated)
- Study start9 Sep 2014
- Primary completion20 Sep 2017
- Study completion29 Sep 2017
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
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 290 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- M. E. Michele Heisler, MD MPA, Principal investigator, VA Ann Arbor Healthcare System, Ann Arbor, MI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01855399
- Sponsor's protocol ID
- IIR 12-412
- Acronym
- VA-TEC
- Status last verified
- Apr 2019
- First submitted
- 13 May 2013
- Last updated
- 12 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Turner CD, Lindsay R, Heisler M. Peer Coaching to Improve Diabetes Self-Management Among Low-Income Black Veteran Men: A Mixed Methods Assessment of Enrollment and Engagement. Ann Fam Med. 2021 Nov-Dec;19(6):532-539. doi: 10.1370/afm.2742.
PubMed 34750128
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technologically Enhanced Coaching (TEC):A Program for Improving Diabetes Outcomes
- ClinicalTrials.gov ID
- NCT01855399
- Acronym / sponsor ID
- VA-TEC / IIR 12-412
- Conditions
- Diabetes
- Keywords
- Peer Support, Self Management, Health Disparities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 290 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 9 Sep 2014 (actual)
- Primary completion
- 20 Sep 2017 (actual)
- Study completion
- 29 Sep 2017 (actual)
- First posted
- 16 May 2013 (estimated)
- Results
- Posted 12 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Peer support programs have been demonstrated to improve glycemic control among Veterans with poor control. This program will expand on this success by putting innovative tools in the hands of Veteran diabetes patients. Veteran coaches who have demonstrated effective control of their own diabetes will be trained to use communication skills to guide their peers through a diabetes education and decision aid. This tool, which is an iPad application, draws the patient in by showing them their personal risk and medication information derived from baseline labs and self-reported survey data. The tool encourages interaction by providing choices of materials to view, using audio-visual elements and incorporating a goal-setting process for developing self-management action steps and questions to discuss with their doctor at their next clinic visit. Ongoing weekly contact between the Veterans is supported by a confidential phone system.
Detailed description
Peer mentoring and support models have been found in two recent VA Randomized Controlled Trials (RCTs) to be more effective than usual care, financial incentives, and usual nurse care management to improve glycemic control in high-risk Veteran patients with poor glycemic control. Such models are important complements to provision of care by formal health care providers as they provide sustained, flexible between-visit support. Peer supporters and coaches can be trained in effective behavioral approaches to support other Veterans' self-management behaviors. Such supporters, however, necessarily lack the content expertise to help Veterans make informed treatment decisions and set health goals with their health care providers. Accordingly, in a recent study the investigators developed and tested a tailored, interactive computer-based tool with diabetes and medication information embedded in the tool's software that peer coaches and other outreach workers can employ to facilitate discussions with patients. Such tailored, interactive tools have been found to be more effective than generic educational and decision support tools in improving clinical and patient-centered outcomes. Moreover, these tools could enhance the sustainability and effectiveness of coaching programs to better prepare patients to set self-management goals and action plans, and to discuss treatment options with their health care providers. With VA support and input from Veterans, the investigators adapted the tailored, interactive computer-based tool for use with and by Veterans with diabetes. The investigators now propose to incorporate this tool into a peer mentor-led diabetes self-management coaching program among predominantly African American Veterans with poor glycemic control at the Detroit VA, a VA health system with high rates of poor risk factor control among diabetes patients. The investigators propose to evaluate this Technology-Enhanced Coaching (TEC) program. Specifically, the investigators propose to:
Aim 1: Test the effectiveness of a technology-enhanced peer coaching (TEC) program in improving glucose control relative to peer coaching without technology enhancement; and, also test the effectiveness of peer support compared to observed usual care. For the "usual care" observed group, the investigators will use electronic health record data to measure A1c levels.
Aim 2: Assess the impact of the intervention on key patient-centered outcomes, including patients' satisfaction and involvement with care, perceived social support, diabetes-specific quality of life, and medication adherence.
Aim 3: Identify patient characteristics associated with engagement in the intervention and mediators and moderators of the intervention's impact on patient outcomes.
In summary, the TEC program builds on the demonstrated strengths of peer support models and of tailored, interactive decision support tools in improving diabetes self-management and outcomes. This study will test incorporation of tailored interactive educational tools into a peer coaching model found in prior VA RCTs to be effective in improving diabetes outcomes.
The tools tested in the proposed intervention will be disseminated for use in other VA sites through a tool kit with training and support materials. Because the intervention addresses barriers to disease management for chronically ill patients, physicians, and case managers, the study may have broader impact on management practices for other chronic illnesses.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peer Coaching + Decision Aid | Experimental | Behavioral: Peer Coaching, Behavioral: Decision AidAll participants will be assigned to one of up to 87 peer coaches, who also are Detroit VA diabetes patients who previously had poor glycemic control but are currently in good control. After their baseline assessment, participants in both arms will receive information on their lab and blood pressure values and will be randomized to one of the two study arms. Participants in the TEC arm will be scheduled for an initial visit with their coach to review the decision aid, which has incorporated their personal baseline data. |
| Peer Coaching Alone | Active comparator | Behavioral: Peer CoachingParticipants randomized to the 'print materials' group will be scheduled for an initial visit with their coach. The coach will then help them list questions and concerns they wish to discuss with their health care provider, practice raising their questions and concerns and develop an action plan to address barriers to self-management they have identified. During the next six months coaches in both arms will call their assigned peers once a week to provide support for their action steps. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- one hospitalization with a diabetes-related ICD-9 code
- two outpatient visits with a diabetes-related ICD-9 code
- at least one prescription for a glucose control medication (insulin or oral agents) or monitoring supplies.
- [70] Potential participants must also have their most recent A1c in the prior 6 months be at least 8.0% if age < 70 or at least 8.5% if age 70+).
Key exclusion criteria (7 listed)
- Using ICD-9 diagnostic codes, the investigators will exclude patients if they have an active substance abuse disorder or serious psychiatric illness:
- We will then send names of the patients to their primary care providers to identify any patients who they do not recommend inviting to participate in the program.
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 |
|---|---|---|
| Peer CoachingAll participants will be assigned to a peer coach, who is a Detroit VA diabetes patient who previously had poor glycemic control but is currently in good control. Participants will receive information on their lab and blood pressure values and will be scheduled for an initial visit with their coach. The coach will then help them list questions and concerns they wish to discuss with their health care provider, practice raising their questions and concerns, and develop an action plan to address barriers to self-management they have identified. During the next six months, coaches will call their assigned peers once a week to provide support for their action steps. | Behavioural | Peer Coaching + Decision Aid, Peer Coaching Alone |
| Decision AidAlso: TECThe iDecide tool is designed to present key tailored, evidence-based information on diabetes and diabetes treatments. Importantly for a peer support intervention, all content information will be provided through the tool, with the role of the peer mentor being to assist the participant to go through the program and participate in helping the patient formulate questions and concerns to discuss with their health care provider, to set their own behavioral goals and action steps, and to help the participant practice raising the issues they plan to discuss with their health care provider. | Behavioural | Peer Coaching + Decision Aid |
Primary outcome
Percent Glycosylated Hemoglobin
Time frame: 6 Month
Percent glycosylated hemoglobin is measured at baseline, 6 months, and 12 months to test the effectiveness of a technology-enhanced peer coaching (TEC) program in improving glucose control relative to peer support alone.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34750128Turner CD, Lindsay R, Heisler M. Peer Coaching to Improve Diabetes Self-Management Among Low-Income Black Veteran Men: A Mixed Methods Assessment of Enrollment and Engagement. Ann Fam Med. 2021 Nov-Dec;19(6):532-539. doi: 10.1370/afm.2742.
- Individual participant dataSharing planned: Undecided
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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.
M. E. Michele Heisler, MD MPA principal investigator
VA Ann Arbor Healthcare System, Ann Arbor, MI
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer Coaching and Decision Aid in people with Diabetes, run by VA Office of Research and Development at 2 sites 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 4 inclusion and 7 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 12 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 12 Jul 2019). 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?
Percent Glycosylated Hemoglobin (time frame: 6 Month). 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 NCT01855399, 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 12 Jul 2019.