COPDNCT04656093
Healthy Mediation Adherence To Transform and Effectively Relieve Symptoms
A study testing Supportive counseling, Education on SMB and Psychoeducation on ATs for maladaptive beliefs (if applicable) in people with COPD and Diabetes, run by Icahn School of Medicine at Mount Sinai at 2 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- COPD, Diabetes, Hypertension
- What is being tested?
- Supportive counseling, Education on SMB and Psychoeducation on ATs for maladaptive beliefs (if applicable)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Jan 2021to 26 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
United States2 sites
Northwestern University
Chicago, Illinois, 60208
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: Self-management Behaviors Among COPD Patients With Multi-Morbidity
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.
Read the 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:
- 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
- COPD, Diabetes, Hypertension
- Being tested
- Supportive counseling, Education on SMB, Psychoeducation on ATs for maladaptive beliefs (if applicable), Psychoeducation on emotional response (if applicable)
- Keywords
- COPD, Intervention, Motivational Interviewing, Cognitive Restructuring, Diabetes, Hypertension
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Diabetes Mellitus, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supportive counselingBehavioural
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.
Education on SMBBehavioural
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)Behavioural
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)Behavioural
Goal is to educate patient on relationship between emotions and COPD + SMB, identify
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Behavioral: Supportive counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 4 Weeks
Secondary outcomes (4)
Medication Adherence Rating Scale (MARS)
Medication Adherence Rating Scale (MARS) to assess asthma, diabetes, hypertension beliefs about asthma, diabetes and hypertension medication adherence. MARS is a 10-item self-reported instrument. Total scores range from 0 (low likelihood of medication adherence) to 10 (high likelihood), with higher score indicating higher likelihood of medication adherence.
Measured: 4 Weeks
Dietary Approaches to Stop Hypertension (DASH-Q)
The Dietary Approaches to Stop Hypertension (DASH-Q) score examines a dietary pattern and examines relations with health outcomes. The overall score ranges from 8 (the lowest adherence) to 40 (the highest adherence).
Measured: 4 Weeks
International Physical Activity Questionnaire (IPAQ)
The purpose of the questionnaires is to provide common instruments that can be used to obtain internationally comparable data on health-related physical activity. The IPAQ results can be reported in categories (low activity levels, moderate activity levels or high activity levels) or as a continuous variable (MET minutes a week). MET minutes represent the amount of energy expended carrying out physical activity.
Measured: 4 Weeks
Illness Perceptions Questionnaire (IPQ scores)
Multi-factorial pencil-and-paper questionnaire which assesses the five cognitive illness representations on a five-point Likert scale. A revised version of this scale, the Illness Perception Questionnaire- Revised (IPQ-R), extended the original scale by adding more items, splitting the control dimension into personal control and treatment control, and incorporating a cyclical timeline dimension, an overall comprehension of illness factor, and an emotional representation. The IPQ is an 80-item instrument, total scale from 0-10, with higher score indicating higher perception of effects on illness.
Measured: 4 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2020
- Study start15 Jan 2021
- Primary completion26 May 2021
- Study completion26 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan P Wisnivesky, Icahn School of Medicine at Mount Sinai
- Investigators
- Juan P Wisnivesky, MD, DrPH, Principal investigator, Icahn School of Medicine at Mount SinaiAlex Federman, MD, MPH, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04656093
- Sponsor's protocol ID
- GCO 14-0666
- Other IDs
- 5R01HL126508-05
- Status last verified
- Jun 2021
- First submitted
- 30 Nov 2020
- Last updated
- 7 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-management Behaviors Among COPD Patients With Multi-Morbidity
- ClinicalTrials.gov ID
- NCT04656093
- Acronym / sponsor ID
- GCO 14-0666
- Conditions
- COPD, Diabetes, Hypertension
- Keywords
- COPD, Intervention, Motivational Interviewing, Cognitive Restructuring, Diabetes, Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- Northwestern University, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 15 Jan 2021 (actual)
- Primary completion
- 26 May 2021 (actual)
- Study completion
- 26 May 2021 (actual)
- First posted
- 7 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Education on SMB, Behavioral: Psychoeducation on ATs for maladaptive beliefs (if applicable), Behavioral: Psychoeducation on emotional response (if applicable)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. |
| Control | Active comparator | Behavioral: Supportive counselingControl group - Supportive counseling for comorbidity management |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supportive counselingParticipants 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. | Behavioural | Control |
| Education on SMBGoal is to educate patient on SMB based on responses during 15-month interview and screener call, and assess patient's motivation for change. | Behavioural | Intervention |
| 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. | Behavioural | Intervention |
| Psychoeducation on emotional response (if applicable)Goal is to educate patient on relationship between emotions and COPD + SMB, identify | Behavioural | Intervention |
Primary outcome
Brief Illness Perception Questionnaire (BIPQ)
Time frame: 4 Weeks
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.
Beliefs about Medicines Questionnaire (BMQ scores)
Time frame: 4 Weeks
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 secondary outcomes
Medication Adherence Rating Scale (MARS)
Time frame: 4 Weeks
Dietary Approaches to Stop Hypertension (DASH-Q)
Time frame: 4 Weeks
International Physical Activity Questionnaire (IPAQ)
Time frame: 4 Weeks
Illness Perceptions Questionnaire (IPQ scores)
Time frame: 4 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan P Wisnivesky, MD, DrPH principal investigator
Icahn School of Medicine at Mount Sinai
Alex Federman, MD, MPH principal investigator
Icahn School of Medicine at Mount Sinai
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supportive counseling, Education on SMB and Psychoeducation on ATs for maladaptive beliefs (if applicable) in people with COPD and Diabetes, run by Icahn School of Medicine at Mount Sinai at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brief Illness Perception Questionnaire (BIPQ) (time frame: 4 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2021.