Will Veterans Engage in Prevention After HRA-guided Shared Decision Making? (ACTIVATE)
調査の概要
詳細な説明
Over half of all deaths, and many illnesses, can be attributed to four modifiable risk factors: tobacco use, overweight/obesity, physical inactivity, and alcohol use. There are clear links between these modifiable factors and heart disease, cancer, chronic lung disease, and stroke which continue to be the leading causes of death in the United States. Significant improvements have been made in controlling conditions that lead to heart disease, cancer and stroke (e.g., hypertension and hyperlipidemia). However, the underlying behavioral factors (e.g., obesity, tobacco use, and physical inactivity) have not been addressed as well. Prevention is particularly important for Veterans because of the high prevalence of significant risk factors for poor health. For example, more than 70% of Veterans Health Administration (VHA) patients are overweight (body mass index [BMI] 25kg/m2) and one-third are obese (BMI 30kg/m2), which is significantly higher than the US population. Smoking also remains a significant problem among Veterans, with VHA enrollment data from 2010 indicating a prevalence of 20%. Younger Veterans are at particularly high risk for developing chronic illnesses because they are more likely to be overweight/obese and smoke more heavily than non-Veterans.
The investigators propose a two-site, two-arm randomized trial measuring the effectiveness of a Shared Decision Making (SDM) intervention in activating Veterans to enroll in effective prevention services, and improve cardiovascular risk, compared to Veterans Administration (VA) usual care. The study will be performed at the Durham and Ann Arbor Veterans Administration Medical Centers (VAMCs). Each arm will have 225 patients; patients will be VA users with at least one modifiable risk factor (obese, inactive, or tobacco user) who are not currently enrolled in a prevention service. The SDM intervention will be conducted by a prevention coach, telephone based, and will use the output from VHA's Healthy Living Assessment (HLA) to engage Veterans in a conversation where individual preferences are matched to behaviors, and choices for specific prevention services. The resulting prevention action plan will be shared with the Veterans primary care team, and documented in the medical record.
Outcomes will be obtained at baseline, 1 month and 6 months after enrollment by blinded research personnel. The primary outcomes will be: 1) proportion enrolled in effective prevention services; and 2) change in the Patient Activation Measure (PAM). The secondary outcome is 10-year risk of coronary events, as measured by Framingham Risk Score (FRS). Process evaluations of the intervention and its implementation will also be conducted to inform future dissemination and implementation should it prove effective.
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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Michigan
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Ann Arbor、Michigan、アメリカ、48105
- VA Ann Arbor Healthcare System, Ann Arbor, MI
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North Carolina
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Durham、North Carolina、アメリカ、27705
- Durham VA Medical Center, Durham, NC
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参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
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:
To be included in the study, patients must meet the following:
- enrolled in primary care at the Durham or Ann Arbor Health Care Systems
- have one modifiable risk factor identified by a healthy living assessment (physical inactivity, overweight or obese by BMI, or tobacco user)
Exclusion Criteria:
Individuals will be excluded if they have any of the following:
- have been hospitalized for a stroke, myocardial infarction or coronary artery revascularization in the past three months
- have an active diagnosis of psychosis
- have any other health condition they feel would impede participation in the study
- reside in a nursing home
- are severely impaired in hearing or speech, so that they cannot respond to telephone calls
- have significant cognitive or memory impairment
- do not have access to a telephone
- are participating in another prevention intervention study
- are already enrolled in a formal prevention service
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:ヘルスサービス研究
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
介入なし:コントロール
普段のお手入れ
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実験的:Intervention
Primary care phone-based prevention coaching using shared decision making following a Healthy Living Assessment
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A series of two phone sessions with a prevention coach.
The first to engage the veteran to choose a preferred prevention program and link them to Patient Aligned Care Team (PACT), and a follow-up call one month later to assess the progress of the prevention plan.
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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 |
---|---|---|
Enrollment in Prevention Services
時間枠:1 and 6 months (cumulative)
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Proportion of veterans enrolled in effective prevention services including weight loss, healthy eating, physical activity, and smoking cessation programs.
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1 and 6 months (cumulative)
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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 |
---|---|---|
Patient Activation Measures (PAM)
時間枠:Baseline assessment
|
Patient Activation Measures (PAM) assesses patients capacity to manage their health.
Improvement in PAM scores indicate responsiveness to interventions and improvements in self-management behaviors.
Minimum score is a zero and maximum is one hundred.
Higher score is better.
The protocol specifies co-primary outcomes with enrollment in prevention services specified as the most clinically relevant
|
Baseline assessment
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Patient Activation Measures
時間枠:1 month assessment
|
Patient Activation Measures (PAM) assesses patients capacity to manage their health.
Improvement in PAM scores indicate responsiveness to interventions and improvements in self-management behaviors.
Minimum score is a zero and maximum is one hundred.
Higher score is better.
The protocol specifies co-primary outcomes with enrollment in prevention services specified as the most clinically relevant
|
1 month assessment
|
Patient Activation Measures
時間枠:6 months assessments
|
Patient Activation Measures (PAM) assesses patients capacity to manage their health.
Improvement in PAM scores indicate responsiveness to interventions and improvements in self-management behaviors.
Minimum score is a zero and maximum is one hundred.
Higher score is better.
The protocol specifies co-primary outcomes with enrollment in prevention services specified as the most clinically relevant
|
6 months assessments
|
Framingham Risk Score
時間枠:Baseline
|
The Framingham Risk Score is a gender-specific algorithm used to estimate the 10-year cardiovascular risk of an individual.
This is not a scale however, lower score indicates less risk.
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Baseline
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Framingham Risk Score
時間枠:6 months
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The Framingham Risk Score is a gender-specific algorithm used to estimate the 10-year cardiovascular risk of an individual.
This is not a scale however, lower score indicates less risk.
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6 months
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協力者と研究者
捜査官
- 主任研究者:Laura J. Damschroder, MPH、VA Ann Arbor Healthcare System, Ann Arbor, MI
- 主任研究者:Eugene Z. Oddone, MD MHSc、Durham VA Medical Center, Durham, NC
出版物と役立つリンク
一般刊行物
- Olsen MK, Stechuchak KM, Hung A, Oddone EZ, Damschroder LJ, Edelman D, Maciejewski ML. A data-driven examination of which patients follow trial protocol. Contemp Clin Trials Commun. 2020 Aug 13;19:100631. doi: 10.1016/j.conctc.2020.100631. eCollection 2020 Sep.
- Oddone EZ, Damschroder LJ, Gierisch J, Olsen M, Fagerlin A, Sanders L, Sparks J, Turner M, May C, McCant F, Curry D, White-Clark C, Juntilla K. A Coaching by Telephone Intervention for Veterans and Care Team Engagement (ACTIVATE): A study protocol for a Hybrid Type I effectiveness-implementation randomized controlled trial. Contemp Clin Trials. 2017 Apr;55:1-9. doi: 10.1016/j.cct.2017.01.007. Epub 2017 Jan 24.
- Oddone EZ, Gierisch JM, Sanders LL, Fagerlin A, Sparks J, McCant F, May C, Olsen MK, Damschroder LJ. A Coaching by Telephone Intervention on Engaging Patients to Address Modifiable Cardiovascular Risk Factors: a Randomized Controlled Trial. J Gen Intern Med. 2018 Sep;33(9):1487-1494. doi: 10.1007/s11606-018-4398-6. Epub 2018 May 7.
- Sloan C, Stechuchak KM, Olsen MK, Oddone EZ, Damschroder LJ, Maciejewski ML. Short-Term VA Health Care Expenditures Following a Health Risk Assessment and Coaching Trial. J Gen Intern Med. 2020 May;35(5):1452-1457. doi: 10.1007/s11606-019-05455-z. Epub 2020 Jan 2.
- Nouri SS, Damschroder LJ, Olsen MK, Gierisch JM, Fagerlin A, Sanders LL, McCant F, Oddone EZ. Health Coaching Has Differential Effects on Veterans with Limited Health Literacy and Numeracy: a Secondary Analysis of ACTIVATE. J Gen Intern Med. 2019 Apr;34(4):552-558. doi: 10.1007/s11606-019-04861-7. Epub 2019 Feb 12.
研究記録日
主要日程の研究
研究開始 (実際)
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 (実際)
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
- CRE 12-288
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
A de-identified, anonymized dataset will be created and shared. Final data sets will be maintained locally until enterprise-level resources become available for long-term storage and access. Guidance on request and distribution processes will be provided by ORD.
A local privacy officer and study statistician will certify that the dataset contains no PHI prior to distribution. Data will be provided to requestor in electronic form.
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米国で製造され、米国から輸出された製品。
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。
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