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Piloting Mindfulness Meditation Program for Underserved Racial Minority Adults With Pulmonary Hypertension (MMPH)

Primary Purpose

Hypertension, Pulmonary

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness Meditation for Pulmonary Hypertension (MMPH)
Sponsored by
State University of New York at Buffalo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension, Pulmonary focused on measuring pulmonary hypertension, racial minority, complementary health approach, integrative therapy, mindfulness-based intervention, symptom management, health-related quality of life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adults (>18 years)
  • PH confirmed by standard guidelines
  • Self-identified as URM person
  • Willingness to participate in the mindfulness practice program for the duration of the study period
  • Able to ambulate independently
  • English-speaking
  • Have access to a mobile phone

Exclusion Criteria:

  • Known pregnancy
  • Have psychiatric conditions requiring hospitalization within the last year
  • Current practitioner of mind-body practices
  • Current user of Mindfulness APP
  • Deaf or hard of hearing

Sites / Locations

  • SUNY at Buffalo School of Nursing

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Treatment Arm

Comparison Arm or Waited List Arm

Arm Description

This treatment Arm will receive MMPH intervention first, while the wait-listed group waits until this group is complete. Then the wait-listed group will receive the same intervention after the first group completes it.

This active comparator Arm will not receive MMPH intervention at the beginning. They will receive the intervention once the Treatment Group completed the intervention.

Outcomes

Primary Outcome Measures

Change is being assessed in Pulmonary Arterial Hypertension Symptom Scale (PAHSS)
Prevalence and Severity of Pulmonary Hypertension related symptoms (range 0 to 10; 0=no symptom severity; 10=high symptom severity)
Change is being assessed in EmPhasis-10
Health-related Quality of Life (range 0 to 50; 0 = high quality of life; 50 = poor quality of life)
Change is being assessed in PHQ-9
Depression Symptom Severity (range from 0 to 27; 0 = no depression; 27 = high depression)

Secondary Outcome Measures

CAMS-R
Cognitive and Affective Mindfulness Scale-Revised (range 10 to 40; 10 = low level of mindfulness; 40 = high level of mindfulness)
SUS-Modified MMPH
System Usability Scale - Modified for MMPH (range 1 - 7; 1 = low acceptability; 7 = high acceptability)
Pulmonary Hypertension- Specific Symptoms Pain, Anxiety, Fatigue, Dyspnea
Self-report Symptom Severity on a scale of 0 to 10 (0=no symptom severity, 10 = high symptom severity)

Full Information

First Posted
March 25, 2022
Last Updated
June 13, 2023
Sponsor
State University of New York at Buffalo
Collaborators
National Center for Advancing Translational Sciences (NCATS)
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1. Study Identification

Unique Protocol Identification Number
NCT05387889
Brief Title
Piloting Mindfulness Meditation Program for Underserved Racial Minority Adults With Pulmonary Hypertension
Acronym
MMPH
Official Title
Piloting an Evidence-based Mobile Mindfulness Practice to Support Self-management Among Underserved and Racial Minority Adults With Pulmonary Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 17, 2022 (Actual)
Primary Completion Date
November 30, 2022 (Actual)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
State University of New York at Buffalo
Collaborators
National Center for Advancing Translational Sciences (NCATS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The MMPH program will include two Zoom-delivered sessions (Weeks #1 & #4), six video-recorded sessions (Weeks #2, #3, #5, #6, #7, #8), and daily mindfulness meditation practice using a mobile APP during an eight-week study period. Similar to the Urban Zen Integrative Therapy intervention, each MMPH session will include Gentle Body Movement (GBM,10-min), Restorative Pose (Pose,10-min), and Body Awareness Meditation (BAM, 20-min). Self-guided audio-video modules of various durations will be available according to participants' preference and level of comfort (5, 10, 20 minutes). The mobile-APP content will reinforce Zoom content such as mindful breathing, GBM of upper extremities, GBM of lower extremities, Pose sitting, Pose lying, and BAM practices. The MMPH content will be tailored to health management needs specific to PH with cultural consideration of mindfulness-related concepts (stress, responding to stress, resiliency).
Detailed Description
Study design: This study will engage community-dwelling URM adults with PH living in Western New York. We will use a two-group comparative study design where waitlisted participants will serve as controls. Considering a 20% attrition rate in a behavioral health intervention study, we aim to enroll a total of 20, with at least 16 participants to address study aims (8-10 in each group). As a pilot study, power analysis is not necessary. Statistical analysis will include descriptive statistics, mixed-effect modeling for repeated measures, and within-group and between-groups comparisons using t-tests or Wilcoxon signed-rank test as appropriate and Cohen's d effect size calculation. Multi-time data collection will be done via daily mobile-APP use. Setting/ Sample: We will recruit PH patients from two PH clinics managed by UB PH Specialists, a local PH support group, and through the CTSI community outreach programs. Recruitment materials will be disseminated to PH physicians, PH support group leaders, and community leaders, inviting patients to participate in the study. Interested patients will contact research staff by phone or email and will be guided to complete the eligibility questionnaire online using REDCAP. If eligible and interested, participants will meet with research staff to provide verbal consent via Zoom after reviewing the Consent Form content. During the meeting, the research staff will review the purpose of the study, study procedures, and risks and benefits. After providing verbal consent, participants will complete the Demographic and Clinical Characteristic questionnaire online. The initial 10 participants enrolled will be scheduled to begin the program, including mutually agreeable Zoom #1 and Zoom #2 appointments. They will also be provided with a de-identified user ID and password to register and download the MMPH APP to his/her personal phone (Table 1- Study Procedure). Intervention: MMPH program will include two Zoom-delivered sessions (Weeks #1 & #4) and the daily practice of Mindfulness meditation using a mobile-APP for an eight-week study period. Similar to the UZIT intervention, each MMPH session will include Gentle Body Movement (GBM,10-min), Restorative Pose (Pose,10-min), and Body Awareness Meditation (BAM, 20-min). Self-guided audio-video modules of various durations will be available according to participants' preference and level of comfort (5, 10, 20 minutes). The mobile-APP content will reinforce Zoom content such as mindful breathing, GBM of upper extremities, GBM of lower extremities, Pose sitting, Pose lying, and BAM practices. The MMPH content will be tailored to health management needs specific to PH with cultural consideration of mindfulness-related concepts (stress, responding to stress, resiliency). Individual Zoom Interviews: will take place at a convenient time during the last week of the study. The primary focus of this interview is to collect qualitative data about their participation experience in the MMPH program. Standard qualitative thematic analysis procedures will be employed. The following open-ended questions will guide the discussion: 1) What are your general impressions of the program?; 2) How does this program affect you in the management of your PH-related symptoms?; 3) What do you like & do not like about the program?; and 4) What improvements would you recommend?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Pulmonary
Keywords
pulmonary hypertension, racial minority, complementary health approach, integrative therapy, mindfulness-based intervention, symptom management, health-related quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
wait-listed control comparative groups
Masking
None (Open Label)
Masking Description
All participants will receive intervention according to the wait-listed control comparative groups. Therefore, masking is not applicable in this study.
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Arm
Arm Type
Experimental
Arm Description
This treatment Arm will receive MMPH intervention first, while the wait-listed group waits until this group is complete. Then the wait-listed group will receive the same intervention after the first group completes it.
Arm Title
Comparison Arm or Waited List Arm
Arm Type
Active Comparator
Arm Description
This active comparator Arm will not receive MMPH intervention at the beginning. They will receive the intervention once the Treatment Group completed the intervention.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness Meditation for Pulmonary Hypertension (MMPH)
Other Intervention Name(s)
MMPH intervention
Intervention Description
Eight weeks of Mindfulness Meditation practice for patients with Pulmonary Hypertension condition. The content will focus on how to apply Mindfulness concepts to the everyday management of symptoms and stress.
Primary Outcome Measure Information:
Title
Change is being assessed in Pulmonary Arterial Hypertension Symptom Scale (PAHSS)
Description
Prevalence and Severity of Pulmonary Hypertension related symptoms (range 0 to 10; 0=no symptom severity; 10=high symptom severity)
Time Frame
Week 1 (baseline), Week 4, Week 8, Week 12, and Week 16
Title
Change is being assessed in EmPhasis-10
Description
Health-related Quality of Life (range 0 to 50; 0 = high quality of life; 50 = poor quality of life)
Time Frame
Week 1 (baseline), Week 4, Week 8, Week 12, and Week 16
Title
Change is being assessed in PHQ-9
Description
Depression Symptom Severity (range from 0 to 27; 0 = no depression; 27 = high depression)
Time Frame
Week 1 (baseline), Week 4, Week 8, Week 12, and Week 16
Secondary Outcome Measure Information:
Title
CAMS-R
Description
Cognitive and Affective Mindfulness Scale-Revised (range 10 to 40; 10 = low level of mindfulness; 40 = high level of mindfulness)
Time Frame
Week 1 (baseline), Week 4, Week 8, Week 12, and Week 16
Title
SUS-Modified MMPH
Description
System Usability Scale - Modified for MMPH (range 1 - 7; 1 = low acceptability; 7 = high acceptability)
Time Frame
Week 8
Title
Pulmonary Hypertension- Specific Symptoms Pain, Anxiety, Fatigue, Dyspnea
Description
Self-report Symptom Severity on a scale of 0 to 10 (0=no symptom severity, 10 = high symptom severity)
Time Frame
Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults (>18 years) PH confirmed by standard guidelines Self-identified as URM person Willingness to participate in the mindfulness practice program for the duration of the study period Able to ambulate independently English-speaking Have access to a mobile phone Exclusion Criteria: Known pregnancy Have psychiatric conditions requiring hospitalization within the last year Current practitioner of mind-body practices Current user of Mindfulness APP Deaf or hard of hearing
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tania Von Visger
Organizational Affiliation
State University of New York at Buffalo School of Nursing
Official's Role
Principal Investigator
Facility Information:
Facility Name
SUNY at Buffalo School of Nursing
City
Buffalo
State/Province
New York
ZIP/Postal Code
14214
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Piloting Mindfulness Meditation Program for Underserved Racial Minority Adults With Pulmonary Hypertension

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