Healthy Mediation Adherence To Transform and Effectively Relieve Symptoms

NCT04656093 | Completed

• 2 other identifiers: GCO 14-06665R01HL126508-05
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

COPD; Diabetes; Hypertension

Keywords

COPD; Intervention; Motivational Interviewing; Cognitive Restructuring; Diabetes; Hypertension

Outcome Measures

Primary Outcomes (2)

• Brief Illness Perception Questionnaire (BIPQ)

  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.

  4 Weeks

• Beliefs about Medicines Questionnaire (BMQ scores)

  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.

  4 Weeks

Secondary Outcomes (4)

• Medication Adherence Rating Scale (MARS)

  4 Weeks

• Dietary Approaches to Stop Hypertension (DASH-Q)

  4 Weeks

• International Physical Activity Questionnaire (IPAQ)

  4 Weeks

• Illness Perceptions Questionnaire (IPQ scores)

  4 Weeks

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Behavioral: Education on SMB; Behavioral: Psychoeducation on ATs for maladaptive beliefs (if applicable); Behavioral: Psychoeducation on emotional response (if applicable)

Control

ACTIVE COMPARATOR

Control group - Supportive counseling for comorbidity management

Behavioral: Supportive counseling

Interventions

Supportive counseling 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.

Control

Education on SMB 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.

Intervention

Psychoeducation on ATs for maladaptive beliefs (if applicable) BEHAVIORAL

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

Intervention

Psychoeducation on emotional response (if applicable) BEHAVIORAL

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

Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• Northwestern University: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (2)

Northwestern University

Chicago, Illinois, 60208, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Diabetes Mellitus; Hypertension

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Juan P Wisnivesky, MD, DrPH

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

• Alex Federman, MD, MPH

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Research coordinators (RCs) and Principal Investigator (Juan Wisnivesky) are blinded to study randomization and treatment arm for each participant.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Of Division of General Internal Medicine

Model Details: The study team will use data from the observational component of the study to identify patients with COPD, Diabetes (DM) and/or Hypertension (HTN).

Study Record Dates

• First Submitted: November 30, 2020
• First Posted: December 7, 2020
• Study Start: January 15, 2021
• Primary Completion: May 26, 2021
• Study Completion: May 26, 2021
• Last Updated: June 7, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)