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Healthy Mediation Adherence To Transform and Effectively Relieve Symptoms

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Mount Sinai Health System

Status

Completed

Conditions

Hypertension
Diabetes
COPD

Treatments

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

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT04656093
GCO 14-0666
5R01HL126508-05 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

All

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

40 participants in 2 patient groups

Intervention
Experimental group
Description:
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.
Treatment:
Behavioral: Psychoeducation on emotional response (if applicable)
Behavioral: Education on SMB
Behavioral: Psychoeducation on ATs for maladaptive beliefs (if applicable)
Control
Active Comparator group
Description:
Control group - Supportive counseling for comorbidity management
Treatment:
Behavioral: Supportive counseling

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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