New Hampshire Medicaid Wellness Incentive Program (NHWIP)
2019年2月18日 更新者：Sarah Pratt、Dartmouth-Hitchcock Medical Center
The New Hampshire Medicaid Wellness Incentive Program (WIP) will address both the health disparity and increased costs by providing incentivized health promotion programs to overweight or obese and/or tobacco-smoking Medicaid beneficiaries receiving services at New Hampshire's 10 regional Community Mental Health Centers (CMHCs).
研究概览
详细说明
In the New Hampshire Medicaid Wellness Incentive Program, multiple program options will fall into two categories: (1) Supported Fitness and Weight Management and (2) Supported Smoking Cessation.
Eligible participants are able to participate in 1 or both of the programs.
The program options for Supported Fitness and Weight Management are: 1. Fitness Club Membership for 12 months, 2. Fitness Club Membership plus weekly meetings with a Health Mentor for 12 months (In SHAPE), 3. Weight Watchers Membership for 12 months, 4. In SHAPE plus Weight Watchers for 12 months.
The options for Supported Smoking Cessation are: 1. Prescriber meeting to discuss smoking cessation treatment options, 2. Prescriber meeting plus NH State Tobacco Helpline, 3. Prescriber meeting plus Telephone-based Cognitive Behavioral Therapy for Smoking Cessation.
Vouchers for memberships to community fitness centers and formal weight loss programs will be provided, as well as incentives for participation and positive outcomes.
An equipoise stratified randomization design will be used to preserve the research benefits of randomization while maintaining the highly valued opportunity for consumer choice.
Research assessments will be conducted at baseline, 3 months, 6 months, 9 months, and 12 months.
研究类型
介入性
注册 (预期的)
2800
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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New Hampshire
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Concord、New Hampshire、美国、03301
- New Hampshire Hospital
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Concord、New Hampshire、美国、03301
- Riverbend Community Mental Health Center
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Derry、New Hampshire、美国、03038
- Center for Life Management
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Dover、New Hampshire、美国、03820
- Community Partners
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Keene、New Hampshire、美国、03431
- Mondadnock Family Services
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Lebanon And Claremont、New Hampshire、美国
- West Central Behavioral Health Care
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Littleton And Conway、New Hampshire、美国
- Northern Human Services
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Manchester、New Hampshire、美国、03103
- The Mental Health Center of Greater Manchester
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Nashua、New Hampshire、美国、03060
- Greater Nashua Mental Health Center at Community Council
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Nashua、New Hampshire、美国
- Harbor Homes
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Plymouth And Laconia、New Hampshire、美国
- Genesis Behavioral Heatlh
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Portsmouth、New Hampshire、美国、03801
- Seacoast Mental Health Center
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria for smoking intervention and weight management intervention:
- Participants must be Medicaid recipients receiving mental health treatment at one of the participating study sites in New Hampshire.
- 18 years or older
Additional Inclusion Criteria for smoking intervention only:
*Smoking 5 or more cigarettes a day or a carbon monoxide level of 5 or higher at screening.
Additional Inclusion Criteria for weight management only:
*Body Mass Index of 30 or higher or 25 or higher and sedentary lifestyle.
Exclusion Criteria for both interventions:
- Diagnosis of dementia or terminal illness (expected to result in death in 1 year or less)
- Nursing home
- Inability to speak or understand English
Additional exclusion Criteria for weight management only:
- Previous participation in the In SHAPE program
- Active eating disorder diagnosis
- Pregnancy
Additional exclusion Criteria for smoking intervention only:
*Active alcohol or drug dependence with use in the past 30 days
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：卫生服务研究
- 分配：随机化
- 介入模型：阶乘赋值
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Incentives
Participants randomly assigned to the incentive arm, will receive cash incentives for engaging in healthy lifestyle behaviors.
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实验性的：No Incentives
Participants randomly assigned to the no incentives arm, will not receive cash incentives for engaging in healthy lifestyle behaviors.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Weight
大体时间：Baseline, 3 months, 6 months, 9 months, 12 months and 1 year post program follow up
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Weight obtained using a scale at each assessment.
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Baseline, 3 months, 6 months, 9 months, 12 months and 1 year post program follow up
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Change in the 6 minute walk test
大体时间：Baseline, 3 months, 6 monhts, 9 months, 12 months, and 1 year post program completion follow up
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Each participant walks as many ft as possible at a brisk pace.
The amount of feet covered in 6 minutes is documented.
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Baseline, 3 months, 6 monhts, 9 months, 12 months, and 1 year post program completion follow up
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Change in Days of Abstinence-Timeline follow back interview for tobacco smokers
大体时间：Baseline, 3 months, 6 months, 9 months, 12 months, and 1 year post program completion follow up
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A timeline follow back interview is completed for the smoking cessation intervention to identify days of abstinence within the assessment period as well as amount of cigarettes smoked.
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Baseline, 3 months, 6 months, 9 months, 12 months, and 1 year post program completion follow up
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Change in Carbon Monoxide Level
大体时间：Baseline, 3 months, 6 months, 9 months, 12 months, and 1 year post program completion follow up
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At each assessment and during the incentive quit cycles, carbon monoxide level is measured to confirm smoking abstinence or not.
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Baseline, 3 months, 6 months, 9 months, 12 months, and 1 year post program completion follow up
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任：Sarah I Pratt, PhD、Dartmouth-Hitchcock Medical Center
- 首席研究员：Kelley Capuchino、State of New Hampshire, Department of Health and Human Services
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Bianco CL, Pratt SI, Ferron JC, Brunette MF. Electronic Cigarette Use During a Randomized Trial of Interventions for Smoking Cessation Among Medicaid Beneficiaries with Mental Illness. J Dual Diagn. 2019 Jul-Sep;15(3):184-191. doi: 10.1080/15504263.2019.1620400. Epub 2019 Jun 6.
- Brunette MF, Pratt SI, Bartels SJ, Scherer EA, Sigmon SC, Ferron JC, Santos M, Williams GE, Kosydar S, Wolfe RS, Lotz D, Capuchino K. Randomized Trial of Interventions for Smoking Cessation Among Medicaid Beneficiaries With Mental Illness. Psychiatr Serv. 2018 Mar 1;69(3):274-280. doi: 10.1176/appi.ps.201700245. Epub 2017 Nov 15.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2012年5月1日
初级完成 (实际的)
2016年4月1日
研究完成 (实际的)
2018年12月1日
研究注册日期
首次提交
2015年1月30日
首先提交符合 QC 标准的
2015年8月4日
首次发布 (估计)
2015年8月5日
研究记录更新
最后更新发布 (实际的)
2019年2月19日
上次提交的符合 QC 标准的更新
2019年2月18日
最后验证
2019年2月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.