Comparison Study of Usual Care vs. Usual Care Plus Community Intervention to Manage Type 2 Diabetes
2019年8月28日 更新者：Maureen Markle-Reid、McMaster University
A Client-Driven Intervention to Support Self-Management Among Community-Living Older Adults With Type 2 Diabetes and Multiple Chronic Conditions
The overall purpose of this research is to examine and compare the effectiveness and costs of a community-based intervention to support self-management with usual primary care for older adults with Type 2 Diabetes Mellitus and multiple chronic conditions and their family caregivers.
Once the study is complete, the investigators will be able to determine if there is any measurable difference in self-care management between usual care plus the intervention versus usual care alone.
研究概览
详细说明
Research Goal
To examine the comparative effectiveness and costs of a community-based intervention to support self-management with usual primary care for older adults with T2DM and Multiple Chronic Conditions and their family caregivers.
Objectives
- To determine if a 6-month, IP, community-based intervention improve self-management compared with usual primary care services?
- To compare the effectiveness of the intervention on HRQoL, physical activity, nutritional status, depression, anxiety, diabetes parameters (blood glucose levels [HbA1c, hypoglycemic episodes]), diabetes-related complications, number of vascular events, social support number of falls, fall risk and medication safety with usual primary care services?
- To determine the effectiveness of the intervention on HRQoL of family caregivers compared with usual primary care?
- To assess whether or not the intervention improves clinical practice behaviours?
- To determine the 6-month costs of use of health services of the intervention compared with usual care, from a social perspective?
- To identify which subgroups of older adults with T2DM and MCC benefit most from the intervention?
- To determine the effectiveness of the intervention based on sex/gender and region?
- To determine the overall feasibility and acceptability of an IP community-based health promotion intervention and what can be identified as barriers and facilitators to implementation?
研究类型
介入性
注册 (实际的)
291
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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Alberta
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Edmonton、Alberta、加拿大
- Edmonton Oliver PCN
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Leduc、Alberta、加拿大、T9E 6W2
- Leduc Beaumont Devon PCN
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Sherwood Park、Alberta、加拿大
- Sherwood Park PCN
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Ontario
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Hamilton、Ontario、加拿大、L8S 4K1
- McMaster University
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Lindsay、Ontario、加拿大
- Ross Memorial Hospital
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London、Ontario、加拿大
- St. Joseph's Health Care
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Peterborough、Ontario、加拿大
- Peterborough Regional Health Centre
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Port Hope、Ontario、加拿大
- Port Hope Community Health Centre
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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
65年 及以上 (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:
- older adults aged 65+
- live in the local vicinity of a participating Diabetes Education Program
- were referred to their Diabetes Education Program within the past 24 months
- competence in English (or access to a translator)
- intention to continue living in the area for the next 6 months
- two reported chronic conditions in addition to T2DM. Individuals with newly diagnosed T2DM as well as those who were already receiving treatment for T2DM will be eligible for inclusion in the study.
Exclusion Criteria:
- score of 20 or less in Montreal Cognitive Assessment (MoCA) test AND without access to a substitute decision maker to sign consent (Score of 20 or less is not in itself an exclusion).
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：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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无干预：Usual Primary Care
Usual Primary Care will be received by half the participants during the course of the Study
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有源比较器：Home Visits and educational support
Intervention comprised of Home Visits and group educational sessions.
Home Visits and will be conducted by Diabetes Education staff in lieu of usual care conducted at the Diabetes clinic.
Lifestyle support and educational will be offered in the form of monthly Diabetes Wellness Days offered in the community where nutrition, exercise and support will be given to help improve self-management of diabetes.
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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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Summary of Diabetes Self-Care Activities
大体时间：Every two months from study onset until the end of study (6 months from baseline)
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The SDSCA is a multidimensional measure of diabetes self-management with adequate internal and test-retest reliability, and evidence of validity and sensitivity to change.
The revised SDSCA consists of items that assess the following aspects of the diabetes regimen: general and specific diet, exercise, blood-glucose testing, foot care, and smoking.
Scores are calculated for each of these five regimen areas.
This data is collected by the interventionists at each visit.
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Every two months from study onset until the end of study (6 months from baseline)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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SF12v2
大体时间：Baseline and end of study (6 months from baseline)
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This measurement is used to assess Health related quality of Life.
This survey consists of 12 questions that measure functional health and well-being from the client's perspective.
It provides scores for eight health domains (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, mental health), and psychometrically-based physical component summary (PCS) and mental component summary (MCS) scores
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Baseline and end of study (6 months from baseline)
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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CES-D-10
大体时间：Baseline and end of study (6 months from baseline)
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The CES-D has been used in prior studies of older adults with mood disorders, and has a high degree of reliability, content, construct and criterion related validity, distinguishes between depressed and non-depressed people, and is a sensitive tool for measuring changes in depressive symptoms over time in psychiatric populations.
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Baseline and end of study (6 months from baseline)
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GAD-7
大体时间：Baseline and end of study (6 months from baseline)
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Prevalence and severity of anxiety, measured by the Generalized Anxiety Disorder Screener
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Baseline and end of study (6 months from baseline)
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Health Assessment forms
大体时间：Baseline intervention interview, at 3 months and again at 6 months
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• Diabetes parameters (fasting blood glucose, HbA1c, hypoglycemic episodes), and presence of diabetes-related complications and comorbid chronic conditions, obtained from health assessment forms submitted by the Diabetes Education Program RN and RD after the first home visit and at 3 months and 6 months.
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Baseline intervention interview, at 3 months and again at 6 months
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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
- 首席研究员：Maureen Markle-Reid, PhD、McMaster University
- 首席研究员：Jenny Ploeg, PhD、McMaster University
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
- Markle-Reid M, Ploeg J, Valaitis R, Duggleby W, Fisher K, Fraser K, Ganann R, Griffith LE, Gruneir A, McAiney C, Williams A. Protocol for a program of research from the Aging, Community and Health Research Unit: Promoting optimal aging at home for older adults with multimorbidity. J Comorb. 2018 Jul 31;8(1):2235042X18789508. doi: 10.1177/2235042X18789508. eCollection 2018.
- Markle-Reid M, Ploeg J, Fraser KD, Fisher KA, Bartholomew A, Griffith LE, Miklavcic J, Gafni A, Thabane L, Upshur R. Community Program Improves Quality of Life and Self-Management in Older Adults with Diabetes Mellitus and Comorbidity. J Am Geriatr Soc. 2018 Feb;66(2):263-273. doi: 10.1111/jgs.15173. Epub 2017 Nov 27.
- Miklavcic JJ, Fraser KD, Ploeg J, Markle-Reid M, Fisher K, Gafni A, Griffith LE, Hirst S, Sadowski CA, Thabane L, Triscott JAC, Upshur R. Effectiveness of a community program for older adults with type 2 diabetes and multimorbidity: a pragmatic randomized controlled trial. BMC Geriatr. 2020 May 13;20(1):174. doi: 10.1186/s12877-020-01557-0.
- Markle-Reid M, Ploeg J, Fraser KD, Fisher KA, Akhtar-Danesh N, Bartholomew A, Gafni A, Gruneir A, Hirst SP, Kaasalainen S, Stradiotto CK, Miklavcic J, Rojas-Fernandez C, Sadowski CA, Thabane L, Triscott JA, Upshur R. The ACHRU-CPP versus usual care for older adults with type-2 diabetes and multiple chronic conditions and their family caregivers: study protocol for a randomized controlled trial. Trials. 2017 Feb 6;18(1):55. doi: 10.1186/s13063-017-1795-9.
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
2014年9月1日
初级完成 (实际的)
2017年5月1日
研究完成 (实际的)
2017年5月1日
研究注册日期
首次提交
2014年6月3日
首先提交符合 QC 标准的
2014年6月6日
首次发布 (估计)
2014年6月9日
研究记录更新
最后更新发布 (实际的)
2019年8月30日
上次提交的符合 QC 标准的更新
2019年8月28日
最后验证
2019年8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.