Clinical trial NCT04656093: Healthy Mediation Adherence To Transform and Effectively Relieve Symptoms
Official title: Self-management Behaviors Among COPD Patients With Multi-Morbidity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Diabetes
Hypertension
Keywords: COPD
Intervention
Motivational Interviewing
Cognitive Restructuring
Diabetes
Hypertension
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: Northwestern University
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2020-12-07
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study team will use data from the observational component of the study to identify patients with COPD, Diabetes (DM) and/or Hypertension (HTN).
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

iii. Self-Management Behaviors (SMB) Finally, the Care Coach will discuss patient's self-management behaviors for their comorbidities. He/she will ask the patient to explain how he/she manages each condition, and any challenges he/she faces in self-management.

For example: "Can you describe to me how you manage your COPD? How about your hypertension?" The Care Coach will use the participant's responses, combined with self-reported and objective medication adherence from the observational study, to determine the focus of the SMB portion of 2nd session.

Eligibility criteria: Inclusion Criteria:

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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Brief Illness Perception Questionnaire (BIPQ)
timeFrame: 4 Weeks
measure: Beliefs about Medicines Questionnaire (BMQ scores)
timeFrame: 4 Weeks
Secondary outcomes:
measure: Medication Adherence Rating Scale (MARS)
timeFrame: 4 Weeks
measure: Dietary Approaches to Stop Hypertension (DASH-Q)
timeFrame: 4 Weeks
measure: International Physical Activity Questionnaire (IPAQ)
timeFrame: 4 Weeks
measure: Illness Perceptions Questionnaire (IPQ scores)
timeFrame: 4 Weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Juan P Wisnivesky, MD, DrPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Icahn School of Medicine at Mount Sinai
name: Alex Federman, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: