Healthy Mediation Adherence To Transform and Effectively Relieve Symptoms

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-15

Study Completion Date

2021-05-26

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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COPD Diabetes Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

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

Study Groups

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Intervention

Intervention group - Cognitive Restructuring, Motivational Interviewing, and Multi-Medication Adherence.

The pilot intervention is comprised of three educational sessions for individual study patients, conducted by interventionist with a master's degree in psychology with cognitive behavioral therapy training. The topics addressed in the sessions are as follows:

Review of COPD medication inhaler technique, psychoeducation on maladaptive beliefs and emotional response.

Group Type EXPERIMENTAL

Education on SMB

Intervention Type BEHAVIORAL

Goal is to educate patient on SMB based on responses during 15-month interview and screener call, and assess patient's motivation for change.

Psychoeducation on ATs for maladaptive beliefs (if applicable)

Intervention Type BEHAVIORAL

Goal is to educate patient on relationship between thoughts and SMB, and identify maladaptive beliefs, automatic thoughts, and cognitive distortions.

Psychoeducation on emotional response (if applicable)

Intervention Type BEHAVIORAL

Goal is to educate patient on relationship between emotions and COPD + SMB, identify

Control

Control group - Supportive counseling for comorbidity management

Group Type ACTIVE_COMPARATOR

Supportive counseling

Intervention Type BEHAVIORAL

Participants in the control arm will receive 3 "placebo" sessions to control for the potentially confounding effect of personalized attention from the care coach on the relationship between the intervention and outcomes. The interventionist will review a patient education booklet for COPD self-management over the 3 sessions and address any question raised by the study subject.

Interventions

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Supportive counseling

Participants in the control arm will receive 3 "placebo" sessions to control for the potentially confounding effect of personalized attention from the care coach on the relationship between the intervention and outcomes. The interventionist will review a patient education booklet for COPD self-management over the 3 sessions and address any question raised by the study subject.

Intervention Type BEHAVIORAL

Education on SMB

Goal is to educate patient on SMB based on responses during 15-month interview and screener call, and assess patient's motivation for change.

Intervention Type BEHAVIORAL

Psychoeducation on ATs for maladaptive beliefs (if applicable)

Goal is to educate patient on relationship between thoughts and SMB, and identify maladaptive beliefs, automatic thoughts, and cognitive distortions.

Intervention Type BEHAVIORAL

Psychoeducation on emotional response (if applicable)

Goal is to educate patient on relationship between emotions and COPD + SMB, identify

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No