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临床试验/NCT04656093
NCT04656093已完成不适用

Self-management Behaviors Among COPD Patients With Multi-Morbidity

Icahn School of Medicine at Mount Sinai3 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年1月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
3
主要终点
Brief Illness Perception Questionnaire (BIPQ)

研究概览

简要总结

The goal of the parent R01 study has been to determine how beliefs about chronic illness and their treatments affect SMB in the context of chronic obstructive pulmonary disease (COPD) with comorbid hypertension (HTN) and or diabetes (DM). The educational counseling modules the study team plans to pilot test are rooted in the Self-Regulation Model (SRM), a theory of health behaviors that has been used to develop interventions, but has only been applied to research on behaviors around single diseases.

详细描述

Outcomes for patients with multimorbidity (MM) are often poor, in part because of low adherence to self-management behaviors (SMB). Research has identified key determinants of SMB for individual diseases and shown the powerful influence that illness representations and medication beliefs have on these behaviors. Yet, little is known about the impact of illness representations in the context of MM where beliefs about one illness and its treatments may be at odds, or symbiotic, with those for comorbidities. Without this knowledge, ability to provide optimal self-management support for MM patients is limited. The Pilot will be focusing on three mayor components with the hopes to provide optimal self-management support for MM patients:

i. Beliefs about Multi-Morbidity The Care Coach will discuss the participant's individual disease & self-management-related beliefs. This discussion will be guided by a semi-structured questionnaire covering domains from Brief Illness Perception Questionnaire (BIPQ) and the Beliefs about Medication Questionnaire (BMQ) for each pertinent multi-morbidity.

For example, the Care Coach will ask: "How long do you believe that your COPD will continue?" "And how about your hypertension, how long will it continue?" The Care Coach will note the participants' responses to each question, and mark which beliefs seem to be potentially counterproductive to self-management (e.g. very concerned about taking DM medications long-term). These beliefs will be used to focus the intervention session section on cognitive restructuring. Beliefs will be addressed using a Cognitive restructuring approach.

ii. Emotional Response Next, the Care Coach will ask the participant about the role of emotional responses and mental state in their disease management. This will consist of 1-2 semi-structured questions about symptoms of anxiety and depression, as well as the emotional impact of each comorbidity in the participant's life.

For example: "Does your COPD affect you emotionally? [If yes] In what ways?" The Care Coach will take notes on the participants' self-reported emotional response to their comorbidities, as well as any observed indications of distress/emotional reaction to their illnesses. This information, combined with the participants' data from the 15-month DISH interview (Diagnostic Interview and Structured Hamilton assessment tool), will be used to determine the focus of the emotional response portion of the intervention.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

Research coordinators (RCs) and Principal Investigator (Juan Wisnivesky) are blinded to study randomization and treatment arm for each participant.

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients will be included in the pilot study if they meet any of the following criteria:
  • Low medication adherence for COPD, hypertension, or diabetes medications (score <4.5 on the Medication Adherence Rating Scale, or adherence rate <70% as measured by electronic dose monitoring at study month 15);
  • Endorsement of any maladaptive illness belief on the Brief Illness Perceptions Questionnaire for COPD, HTN, or DM;
  • Endorsement of any maladaptive medication belief on the Brief Medication Questionnaire for COPD, HTN, or DM.

排除标准

  • Adequate medication adherence for COPD
  • Adequate medication adherence for hypertension
  • Adequate medication adherence for diabetes medications
  • Score ≥4.5 on Medication Adherence Rating Scale, or adherence rate ≥70% as measured by electronic dose monitoring at Study Month 15.

结局指标

主要结局

Brief Illness Perception Questionnaire (BIPQ)

时间窗: 4 Weeks

A nine-item scale designed to rapidly assess the cognitive and emotional representations of illness. Full scale range 0 to 10. A higher score reflects a more threatening view of the illness.

Beliefs about Medicines Questionnaire (BMQ scores)

时间窗: 4 Weeks

The BMQ assess beliefs about medications. The BMQ has two components: beliefs about overuse (score range from 3-15) and perceived risk of medicines (score range from 5-25), total scale 8-40, higher score indicates stronger beliefs in the concepts of the scale.

次要结局

  • Dietary Approaches to Stop Hypertension (DASH-Q)(4 Weeks)
  • International Physical Activity Questionnaire (IPAQ)(4 Weeks)
  • Medication Adherence Rating Scale (MARS)(4 Weeks)
  • Illness Perceptions Questionnaire (IPQ scores)(4 Weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Juan P Wisnivesky

Chief Of Division of General Internal Medicine

Icahn School of Medicine at Mount Sinai

研究点 (3)

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