Harnessing Health IT for Self-Management Support and Medication Activation in a Medicaid Health Plan (SMARTSteps)
調査の概要
詳細な説明
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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California
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San Francisco、California、アメリカ、94110
- Center for Vulnerable Populations
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- 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
Exclusion Criteria:
- Pregnant
- Unable to provide verbal consent
- Leaving the region in the next 12 months
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:支持療法
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
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アクティブコンパレータ:ATSM Intervention
ATSM Intervention: Automated Telephone Self-Management Support.
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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.
他の名前:
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介入なし:WAIT LIST Control
WAIT LIST Control: six month Wait List.
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Changes in the Physical Component Summary of the SF-12 Health Survey
時間枠:Baseline and 6 months
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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.
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Baseline and 6 months
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Changes in the Mental Component Summary of the SF-12 Health Survey
時間枠:Baseline and 6 months
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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.
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Baseline and 6 months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Number of Days Spent in Bed Due to Illness
時間枠:6 months
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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.
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6 months
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Proportion of Patients Reporting Diabetes Interference of Normal Daily Activities
時間枠:6 months
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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.
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6 months
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Changes in Diabetes Self-management Behaviors as Measured by Summary of Diabetes Self-Care Activities (SDSCA) Scale
時間枠:Baseline and 6 months
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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.
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Baseline and 6 months
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Changes in Self-reported Medication Adherence as Measured by Summary of Diabetes Self-Care Activities (SDSCA) Scale
時間枠:Baseline and 6 months
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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.
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Baseline and 6 months
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Changes in Diabetes Self-efficacy as Measured by Diabetes Quality Improvement Project's Patient Self-Management Scale
時間枠:Baseline and 6 months
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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.
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Baseline and 6 months
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Changes in Patient-centeredness of Care as Measured by Patient Assessment of Chronic Illness Care (PACIC) Scale
時間枠:Baseline and 6 months
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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.
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Baseline and 6 months
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Changes in Patient-centeredness of Care as Measured by Interpersonal Processes of Care (IPC) Scale
時間枠:Baseline and 6 months
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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.
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Baseline and 6 months
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Changes in Hemoglobin A1c Levels
時間枠:Baseline and 6 months
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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.
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Baseline and 6 months
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Changes in Systolic Blood Pressure (SBP)
時間枠:Baseline and 6 months
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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.
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Baseline and 6 months
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Changes in Diastolic Blood Pressure (DBP)
時間枠:Baseline and 6 months
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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.
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Baseline and 6 months
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協力者と研究者
捜査官
- 主任研究者:Dean Schillinger, MD、University of California, San Francisco
出版物と役立つリンク
一般刊行物
- 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.
- Quan 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.
- Ratanawongsa 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.
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- R18HS017261 (米国 AHRQ グラント/契約)
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
ATSM Interventionの臨床試験
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Institut Cancerologie de l'OuestFondation ARC積極的、募集していない
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Collaborative Medicinal Development Pty Limitedわからない
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University of California, San FranciscoNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)完了
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University of MichiganNational Institute on Drug Abuse (NIDA)完了
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University of Southern CaliforniaNational Institutes of Health (NIH)積極的、募集していない