Healthy Mediation Adherence To Transform and Effectively Relieve Symptoms

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.

Conditions

• COPD
• Diabetes
• Hypertension

Interventions

BEHAVIORAL

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.

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.

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.

BEHAVIORAL

Psychoeducation on emotional response (if applicable)

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

Sponsors & Collaborators

• Northwestern University

  collaborator OTHER

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• Icahn School of Medicine at Mount Sinai

  lead OTHER

Principal Investigators

• Juan P Wisnivesky, MD, DrPH · Icahn School of Medicine at Mount Sinai

• Alex Federman, MD, MPH · Icahn School of Medicine at Mount Sinai

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-01-15

Primary Completion

2021-05-26

Completion

2021-05-26

Countries

• United States

Study Locations