DiabetesSMARTStepsNCT00683020
Harnessing Health IT for Self-Management Support and Medication Activation in a Medicaid Health Plan
A study testing ATSM Intervention in people with Diabetes, run by University of California, San Francisco at 1 site in United States.
Trial summary
To measure the effects of a Medical health plan-directed automated telephone self-management support system (ATSM) on patient outcomes among ethnically diverse health plan enrollees with diabetes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes
- What is being tested?
- ATSM Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 362 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Apr 2012
- 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
- Diabetes diagnosis
- Attend one of 4 CHNSF clinics
- Ages 18 or above
- Speak English, Spanish or Cantonese
- Have a touch tone phone
- Have had one or more clinic visits in the preceding 24 months
- Will be in the SF Bay Area for the following six months
Who cannot join
- Pregnant
- Unable to provide verbal consent
- Leaving the region in the next 12 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Vulnerable Populations
San Francisco, California, 94110
About this study
To measure the effects of a Medical health plan-directed automated telephone self-management support system (ATSM) on patient outcomes among ethnically diverse health plan enrollees with diabetes.
Read the detailed description
We will be conducting an evaluation of a quality improvement initiative that the San Francisco Health Plan (SFHP), a large Medicaid managed care plan in SF, is conducting for approximately 500 SFHP enrollees with diabetes who are attending 4 Community Health Network Clinics in San Francisco (CHNSF) over a two year period. The intervention that SFHP is implementing is Automated Telephone Support Management (ATSM), a health IT innovation used as adjunct to care management. The partnership with University of California, San Francisco-San Francisco General Hospital (UCSF-SFGH) researchers is based on previous work we have done in the CHNSF regarding using ATSM among diabetes patients to improve self-management activities and other health outcomes,but in the current demonstration project and evaluation, the recruitment of participants and implementation of the intervention will be done by the SFHP; UCSF will only conduct an evaluation. The Governing Board at the SFHP decided to adopt the ATSM model for its growing number of diabetes patients, to dedicate nursing staff to respond to ATSM data and engage with enrollees and their providers, to underwrite the costs of ATSM implementation, to randomly assign their patients to one of two types of ATSM (one that involves medication review/intensification vs. one that only delivers behavioral support), and to contact eligible SFHP members for ATSM and also to briefly describe the evaluation study to be carried out by UCSF. We, as UCSF researchers, will evaluate the impact of the interventions on patient outcomes. There will be limited contact with patients by the UCSF research team. UCSF research staff will only contact patients after SFHP has determined that their patients are interested in being contacted about the evaluation; and there will be no collection of personal health information by UCSF evaluators. UCSF research staff will conduct a telephone survey after verbal consent procedures, at baseline and 6 months (and for patients wait-listed, again at 12 months), for patients participating in the ATSM intervention. The SFHP will maintain an identification (ID) link between patients who are in the intervention and who are conducted about the evaluation, but they will not have patient-linked survey data, nor will UCSF have linked health-related data from the SFHP regarding patient outcomes, although de-identified data will be included in the UCSF evaluation. UCSF will conduct the quantitative data analyses of de-identified data provided to us by the SFHP at set times over the study period to examine the impact of the interventions on clinical outcomes. The evaluation will focus on the effects of ATSM on both patient-centered outcomes and on clinical outcomes through this "real-world" effectiveness study. The fact that recruitment and implementation will be carried out by SFHP, that SFHP will maintain the link to patients in the evaluation but will not have the survey data linked to individuals, and that only SFHP will have control over the personal health information of patients, has important implications for generalizability.
- Conditions
- Diabetes
- Being tested
- ATSM Intervention
- Keywords
- Chronic Diseases, Diabetes, Vulnerable population, Urban populations, Disease Management, Health Information Technology, Safety, Health Literacy, Level of English Proficiency
- Medical subject headings
- Diabetes Mellitus, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATSM InterventionBehavioural
Also called ATSM: Automated Telephone Self-Management Support
The ATSM system is designed to promote the efficiency of a care manager by having her focus outreach phone calls to patients who, by virtue of their responses to the ATSM system, report a need for further support. The purpose of these call-backs is to have the care manager directly engage patients in setting goals and developing an action plan to improve their overall health. The care manager is trained to perform motivational interviewing, assess and overcome barriers to health communication.
For some patients, the ATSM system as described above is augmented by additional phone communications from care manager to patient, triggered by health IT derived from 2 additional data sources: SFHP pharmacy claims data and CHNSF diabetes registry. The latter combines clinical data (labs and blood pressure). Based on clinical criteria, the ATSM system will alert care manager to make additional calls to patients.
| Study group | Role | What they receive |
|---|---|---|
| ATSM Intervention | Active comparator | ATSM Intervention: Automated Telephone Self-Management Support. Receives: Behavioral: ATSM Intervention |
| WAIT LIST Control | No intervention | WAIT LIST Control: six month Wait List. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the Physical Component Summary of the SF-12 Health Survey
The SF-12 Health Survey (SF-12) is a 12-item short-form survey used to measure health status and monitor health outcomes. The survey asks about various health aspects, including physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health (psychological distress and psychological well-being). Two summary measures are derived: the Physical and the Mental Health Component Summary. For each component summary, survey items were weighted and summed to create a summary score between 0 and 100 with higher score indicating better functioning and outcome. Change is calculated as 6-month score minus baseline score.
Measured: Baseline and 6 months
Changes in the Mental Component Summary of the SF-12 Health Survey
The SF-12 Health Survey (SF-12) is a 12-item short-form survey used to measure health status and monitor health outcomes. The survey asks about various health aspects, including physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health (psychological distress and psychological well-being). Two summary measures are derived: the Physical and the Mental Health Component Summary. For each component summary, survey items were weighted and summed to create a summary score between 0 and 100 with higher score indicating better functioning and outcome. Change is calculated as 6-month score minus baseline score.
Measured: Baseline and 6 months
Secondary outcomes (10)
Number of Days Spent in Bed Due to Illness
A measure of patients' functional status is ascertained by asking patients the following question: "In the last 30 days, how many days did health problems keep you in bed for all or most of the day?" Number of days may range from 0 to 30, with lower number of days indicating better functional status. Because a negative binomial model was used to analyze the data for number of days spent in bed due to illness, log means are reported. A log mean is the natural (base e) logarithm of the mean (in this context specifically, the mean number of days spent in bed due to illness). To calculate the mean, one raises e by the number given as the log mean. Lower log means indicate better functional status.
Measured: 6 months
Proportion of Patients Reporting Diabetes Interference of Normal Daily Activities
A measure of diabetes interference on patients is ascertained by asking patients the following question: "In the last 6 months, how often has your diabetes kept you from doing your normal daily activities, such as going to work, grocery shopping, and taking care of yourself and others?" Responses consist of 6 possible options: "Always", "Almost Always", "Often", "Sometimes", "Almost Never", and "Never". These responses are grouped into 2 categories, with one category consisting of "Always", "Almost Always", and "Often" responses while the other category consists of the remaining responses. The proportion of patients reporting diabetes interference is the number of patients in the first category divided by the number of patients in the 2 categories combined.
Measured: 6 months
Changes in Diabetes Self-management Behaviors as Measured by Summary of Diabetes Self-Care Activities (SDSCA) Scale
The Summary of Diabetes Self-Care Activities (SDSCA) Measure is a brief self-report questionnaire on diabetes self-management behaviors. The questionnaire assesses the frequency with which a patient followed a diabetes routine over the prior 7 days in five domains: diet, exercise, blood-glucose testing, foot care, and medication adherence. Based on SDSCA measure's author's recommendations, two separate scores are derived: a Diabetes Self-management Behaviors score and a Self-reported Medication Adherence score. For the Diabetes Self-management Behaviors score, all items pertaining to diet, exercise, blood glucose testing, and foot care are averaged. For the Self-reported Medication Adherence score, all items pertaining to medication use are averaged. For both scores, the result is an average score between 0 and 7 with higher score indicating better diabetes self-management behavior or better medication adherence. Change is calculated as 6-month score minus baseline score.
Measured: Baseline and 6 months
Changes in Self-reported Medication Adherence as Measured by Summary of Diabetes Self-Care Activities (SDSCA) Scale
The Summary of Diabetes Self-Care Activities (SDSCA) Measure is a brief self-report questionnaire on diabetes self-management behaviors. The questionnaire assesses the frequency with which a patient followed a diabetes routine over the prior 7 days in five domains: diet, exercise, blood-glucose testing, foot care, and medication adherence. Based on SDSCA measure's author's recommendations, two separate scores are derived: a Diabetes Self-management Behaviors score and a Self-reported Medication Adherence score. For the Diabetes Self-management Behaviors score, all items pertaining to diet, exercise, blood glucose testing, and foot care are averaged. For the Self-reported Medication Adherence score, all items pertaining to medication use are averaged. For both scores, the result is an average score between 0 and 7 with higher score indicating better diabetes self-management behavior or better medication adherence. Change is calculated as 6-month score minus baseline score.
Measured: Baseline and 6 months
Changes in Diabetes Self-efficacy as Measured by Diabetes Quality Improvement Project's Patient Self-Management Scale
The Patient Self-Management Scale was derived from a questionnaire used in the Diabetes Quality Improvement Project. The scale is designed to reflect patients' assessment of their ability to manage aspects of diabetes self-care in 5 separate areas (medication, diet, exercise, blood glucose monitoring, and foot care). Respondents are asked how difficult over the past 6 months has it been to follow exactly as their doctor who takes care of their diabetes suggested. Possible scores for each scale item range from 0 to 100 with higher score indicating more self-efficacy. Total scale score is calculated as the average across all items. Change is calculated as 6-month score minus baseline score.
Measured: Baseline and 6 months
Changes in Patient-centeredness of Care as Measured by Patient Assessment of Chronic Illness Care (PACIC) Scale
The Patient Assessment of Chronic Illness Care (PACIC) is a 20-item patient report instrument that measures patients' perspectives on the structure of their care and collects patient reports on the extent to which they have received specific clinical services and actions during the past 6 months that are aligned with the Chronic Care Model. The scale is intended to assess the receipt of care that is patient-centered, proactive, planned and includes collaborative goal setting, problem-solving and follow-up support. Each instrument item is scored on a 5-point scale ranging from 1 to 5 with higher score indicating better care. Scores are transformed to a 100-point scale (0-100) and averaged across all items to create a total scale score. Higher transformed and total scale scores indicate better care. Change is calculated as 6-month score minus baseline score.
Measured: Baseline and 6 months
Changes in Patient-centeredness of Care as Measured by Interpersonal Processes of Care (IPC) Scale
The Interpersonal Processes of Care (IPC) is an 18-item patient report instrument that measures patients' perspectives on the structure of their care and collects patient reports on providers' communication over the prior 6 months. The scale is intended to measure patients' assessment of providers' communication within 3 broad domains: communication (e.g., lack of clarity), decision making (e.g., patient-centered decision making), and interpersonal style (e.g., friendliness). Each instrument item is scored on a 5-point scale ranging from 1 to 5. Scores are transformed to a 100-point scale and averaged across all items to create a total scale score. Higher total scores indicate better communication. Change is calculated as 6-month score minus baseline score.
Measured: Baseline and 6 months
Changes in Hemoglobin A1c Levels
Hemoglobin A1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. As the average amount of plasma glucose increases, the fraction of hemoglobin A1c increases in a predictable way. This serves as a marker for average blood glucose levels over the previous months prior to the measurement. Higher amounts of hemoglobin A1c indicate poorer control of blood glucose levels and have been associated with cardiovascular disease. Change is calculated as 6-month level minus baseline level.
Measured: Baseline and 6 months
Changes in Systolic Blood Pressure (SBP)
Systolic blood pressure is the pressure exerted on arteries and vessels by the heart when it contracts and pushes blood through the arteries to the rest of the body. Change is calculated as 6-month pressure minus baseline pressure.
Measured: Baseline and 6 months
Changes in Diastolic Blood Pressure (DBP)
Diastolic blood pressure is the pressure exerted on the walls of the arteries and vessels in between heart beats, when the heart is relaxed and dilated, filling with blood. Change is calculated as 6-month pressure minus baseline pressure.
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2008 (estimated)
- Study startApr 2009
- Primary completionNov 2011
- Study completionApr 2012
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 (3)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 362 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- San Francisco Health Plan (SFHP), Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Sponsor
- Investigators
- Dean Schillinger, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00683020
- Sponsor's protocol ID
- R18HS017261
- Acronym
- SMARTSteps
- Status last verified
- May 2013
- First submitted
- 21 May 2008
- Last updated
- 15 May 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Ratanawongsa N, Quan J, Handley MA, Sarkar U, Schillinger D. Language-concordant automated telephone queries to assess medication adherence in a diverse population: a cross-sectional analysis of convergent validity with pharmacy claims. BMC Health Serv Res. 2018 Apr 6;18(1):254. doi: 10.1186/s12913-018-3071-4.
PubMed 29625571Quan J, Lee AK, Handley MA, Ratanawongsa N, Sarkar U, Tseng S, Schillinger D. Automated Telephone Self-Management Support for Diabetes in a Low-Income Health Plan: A Health Care Utilization and Cost Analysis. Popul Health Manag. 2015 Dec;18(6):412-20. doi: 10.1089/pop.2014.0154. Epub 2015 Jun 23.
PubMed 26102298Ratanawongsa N, Handley MA, Quan J, Sarkar U, Pfeifer K, Soria C, Schillinger D. Quasi-experimental trial of diabetes Self-Management Automated and Real-Time Telephonic Support (SMARTSteps) in a Medicaid managed care plan: study protocol. BMC Health Serv Res. 2012 Jan 26;12:22. doi: 10.1186/1472-6963-12-22.
PubMed 22280514
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Harnessing Health IT for Self-Management Support and Medication Activation in a Medicaid Health Plan
- ClinicalTrials.gov ID
- NCT00683020
- Acronym / sponsor ID
- SMARTSteps / R18HS017261
- Conditions
- Diabetes
- Keywords
- Chronic Diseases, Diabetes, Vulnerable population, Urban populations, Disease Management, Health Information Technology, Safety, Health Literacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 362 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- San Francisco Health Plan (SFHP), Agency for Healthcare Research and Quality (AHRQ)
- Study start
- Apr 2009
- Primary completion
- Nov 2011 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 23 May 2008 (estimated)
- Results
- Posted 15 May 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To measure the effects of a Medical health plan-directed automated telephone self-management support system (ATSM) on patient outcomes among ethnically diverse health plan enrollees with diabetes.
Detailed description
We will be conducting an evaluation of a quality improvement initiative that the San Francisco Health Plan (SFHP), a large Medicaid managed care plan in SF, is conducting for approximately 500 SFHP enrollees with diabetes who are attending 4 Community Health Network Clinics in San Francisco (CHNSF) over a two year period. The intervention that SFHP is implementing is Automated Telephone Support Management (ATSM), a health IT innovation used as adjunct to care management. The partnership with University of California, San Francisco-San Francisco General Hospital (UCSF-SFGH) researchers is based on previous work we have done in the CHNSF regarding using ATSM among diabetes patients to improve self-management activities and other health outcomes,but in the current demonstration project and evaluation, the recruitment of participants and implementation of the intervention will be done by the SFHP; UCSF will only conduct an evaluation. The Governing Board at the SFHP decided to adopt the ATSM model for its growing number of diabetes patients, to dedicate nursing staff to respond to ATSM data and engage with enrollees and their providers, to underwrite the costs of ATSM implementation, to randomly assign their patients to one of two types of ATSM (one that involves medication review/intensification vs. one that only delivers behavioral support), and to contact eligible SFHP members for ATSM and also to briefly describe the evaluation study to be carried out by UCSF. We, as UCSF researchers, will evaluate the impact of the interventions on patient outcomes. There will be limited contact with patients by the UCSF research team. UCSF research staff will only contact patients after SFHP has determined that their patients are interested in being contacted about the evaluation; and there will be no collection of personal health information by UCSF evaluators. UCSF research staff will conduct a telephone survey after verbal consent procedures, at baseline and 6 months (and for patients wait-listed, again at 12 months), for patients participating in the ATSM intervention. The SFHP will maintain an identification (ID) link between patients who are in the intervention and who are conducted about the evaluation, but they will not have patient-linked survey data, nor will UCSF have linked health-related data from the SFHP regarding patient outcomes, although de-identified data will be included in the UCSF evaluation. UCSF will conduct the quantitative data analyses of de-identified data provided to us by the SFHP at set times over the study period to examine the impact of the interventions on clinical outcomes. The evaluation will focus on the effects of ATSM on both patient-centered outcomes and on clinical outcomes through this "real-world" effectiveness study. The fact that recruitment and implementation will be carried out by SFHP, that SFHP will maintain the link to patients in the evaluation but will not have the survey data linked to individuals, and that only SFHP will have control over the personal health information of patients, has important implications for generalizability.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ATSM Intervention | Active comparator | Behavioral: ATSM InterventionATSM Intervention: Automated Telephone Self-Management Support. |
| WAIT LIST Control | No intervention | –WAIT LIST Control: six month Wait List. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diabetes diagnosis
- Attend one of 4 CHNSF clinics
- Ages 18 or above
- Speak English, Spanish or Cantonese
- Have a touch tone phone
Key exclusion criteria (3 listed)
- Pregnant
- Unable to provide verbal consent
- Leaving the region in the next 12 months
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 |
|---|---|---|
| ATSM InterventionAlso: ATSM: Automated Telephone Self-Management SupportThe ATSM system is designed to promote the efficiency of a care manager by having her focus outreach phone calls to patients who, by virtue of their responses to the ATSM system, report a need for further support. The purpose of these call-backs is to have the care manager directly engage patients in setting goals and developing an action plan to improve their overall health. The care manager is trained to perform motivational interviewing, assess and overcome barriers to health communication. For some patients, the ATSM system as described above is augmented by additional phone communications from care manager to patient, triggered by health IT derived from 2 additional data sources: SFHP pharmacy claims data and CHNSF diabetes registry. The latter combines clinical data (labs and blood pressure). Based on clinical criteria, the ATSM system will alert care manager to make additional calls to patients. | Behavioural | ATSM Intervention |
Primary outcome
Changes in the Physical Component Summary of the SF-12 Health Survey
Time frame: Baseline and 6 months
The SF-12 Health Survey (SF-12) is a 12-item short-form survey used to measure health status and monitor health outcomes. The survey asks about various health aspects, including physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health (psychological distress and psychological well-being). Two summary measures are derived: the Physical and the Mental Health Component Summary. For each component summary, survey items were weighted and summed to create a summary score between 0 and 100 with higher score indicating better functioning and outcome. Change is calculated as 6-month score minus baseline score.
Changes in the Mental Component Summary of the SF-12 Health Survey
Time frame: Baseline and 6 months
The SF-12 Health Survey (SF-12) is a 12-item short-form survey used to measure health status and monitor health outcomes. The survey asks about various health aspects, including physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health (psychological distress and psychological well-being). Two summary measures are derived: the Physical and the Mental Health Component Summary. For each component summary, survey items were weighted and summed to create a summary score between 0 and 100 with higher score indicating better functioning and outcome. Change is calculated as 6-month score minus baseline score.
10 secondary outcomes
Number of Days Spent in Bed Due to Illness
Time frame: 6 months
Proportion of Patients Reporting Diabetes Interference of Normal Daily Activities
Time frame: 6 months
Changes in Diabetes Self-management Behaviors as Measured by Summary of Diabetes Self-Care Activities (SDSCA) Scale
Time frame: Baseline and 6 months
Changes in Self-reported Medication Adherence as Measured by Summary of Diabetes Self-Care Activities (SDSCA) Scale
Time frame: Baseline and 6 months
Changes in Diabetes Self-efficacy as Measured by Diabetes Quality Improvement Project's Patient Self-Management Scale
Time frame: Baseline and 6 months
Changes in Patient-centeredness of Care as Measured by Patient Assessment of Chronic Illness Care (PACIC) Scale
Time frame: Baseline and 6 months
Changes in Patient-centeredness of Care as Measured by Interpersonal Processes of Care (IPC) Scale
Time frame: Baseline and 6 months
Changes in Hemoglobin A1c Levels
Time frame: Baseline and 6 months
Changes in Systolic Blood Pressure (SBP)
Time frame: Baseline and 6 months
Changes in Diastolic Blood Pressure (DBP)
Time frame: Baseline and 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29625571Ratanawongsa N, Quan J, Handley MA, Sarkar U, Schillinger D. Language-concordant automated telephone queries to assess medication adherence in a diverse population: a cross-sectional analysis of convergent validity with pharmacy claims. BMC Health Serv Res. 2018 Apr 6;18(1):254. doi: 10.1186/s12913-018-3071-4.
- Derived from this study: PubMed 26102298Quan J, Lee AK, Handley MA, Ratanawongsa N, Sarkar U, Tseng S, Schillinger D. Automated Telephone Self-Management Support for Diabetes in a Low-Income Health Plan: A Health Care Utilization and Cost Analysis. Popul Health Manag. 2015 Dec;18(6):412-20. doi: 10.1089/pop.2014.0154. Epub 2015 Jun 23.
- Derived from this study: PubMed 22280514Ratanawongsa N, Handley MA, Quan J, Sarkar U, Pfeifer K, Soria C, Schillinger D. Quasi-experimental trial of diabetes Self-Management Automated and Real-Time Telephonic Support (SMARTSteps) in a Medicaid managed care plan: study protocol. BMC Health Serv Res. 2012 Jan 26;12:22. doi: 10.1186/1472-6963-12-22.
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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.
Dean Schillinger, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ATSM Intervention in people with Diabetes, run by University of California, San Francisco 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 7 inclusion and 3 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 15 May 2013. 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 15 May 2013). 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?
Changes in the Physical Component Summary of the SF-12 Health Survey (time frame: Baseline and 6 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 NCT00683020, which also lists 3 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 15 May 2013.