NCT06878898

Brief Summary

The purpose of this pilot study was to:

  1. 1.partner with African American churches to increase awareness of COPD.
  2. 2.use a community-based approach to facilitate early detection of COPD in the church setting. The pre-screening with a paper-based tool and spirometry testing were provided at community health fairs at the churches.
  3. 3.determine the impact of a combined intervention (education and mobile phone/text messages) on health related-related quality of life and health behaviors of African Americans with asthma and COPD.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
6.2 years until next milestone

First Submitted

Initial submission to the registry

June 1, 2023

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

March 17, 2025

Completed
Last Updated

March 17, 2025

Status Verified

March 1, 2025

Enrollment Period

7 months

First QC Date

June 1, 2023

Last Update Submit

March 12, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • Disease Knowledge: Knowledge and Management Questionnaire

    Disease Knowledge: A knowledge questionnaire on basic disease concepts and management practices

    Baseline, 3 months after ACOPD workshop, 9-months post-ACOPD workshop

  • Health-related quality of life (HRQOL) in participants with Chronic Obstructive Pulmonary Disease (COPD)

    Health-related quality of life: The validated Clinical COPD Questionnaire used to measure HRQOL. The scores range from 0 to 6, higher values indicate poorer health status, and a change in score \>0.4 is considered clinically important.

    Baseline, 3 months after ACOPD workshop, 9-months post-ACOPD workshop

  • Health-related quality of life in participants with Asthma

    Health-related quality of life at baseline: The validated 15-item mini-Asthma Quality of Life Questionnaire (mAQLQ) used to measure HRQOL. The scores range from 1-7, higher scores indicate better health status, and a change in score \>0.5 is considered clinically important.

    Baseline, 3 months after ACOPD workshop, 9-months post-ACOPD workshop

Secondary Outcomes (2)

  • Respiratory management behaviors

    Baseline, 3 months after ACOPD workshop, 9-months post-ACOPD workshop

  • Self-efficacy

    Baseline, 3 months after ACOPD workshop, 9-months post-ACOPD workshop

Study Arms (2)

Education (Asthma COPD Workshop) and mobile phone

EXPERIMENTAL

The ACOPD Workshop comprised of 1-hour educational sessions on basic disease knowledge (one session) and management practices (two sessions). Participants were given: * devices and items to encourage behavioral change related to the intervention i.e., pedometers, pocket calendars (tracking physical activity) and pill boxes (medication adherence) * handouts on asthma, COPD developed based on the ACOPD Workshop content asthma and COPD action plan templates from the American Lung Association (ALA) and Asthma and Allergy Foundation of America (AAAF) to encourage dialogue with their healthcare provider, and * a certificate of completion for those that attended all three sessions. * The mobile text messaging provided informational support to reinforce the importance of the core health behaviors presented in the educational sessions. Participants in the intervention arm received text messages once per day over four weeks.

Behavioral: Education and mobile phone text-messaging

Education only

ACTIVE COMPARATOR

The ACOPD Workshop comprised of 1-hour educational sessions on basic disease knowledge (one session) and management practices (two sessions) i.e., three core health behaviors (nutrition, physical activity, and avoiding triggers) recommended for proper management of asthma and COPD. Participants were given: * devices and items to encourage behavioral change related to the intervention i.e., pedometers, pocket calendars (tracking physical activity) and pill boxes (medication adherence) * handouts on asthma, COPD developed based on the ACOPD Workshop content * asthma and COPD action plan templates from the American Lung Association (ALA) and Asthma and Allergy Foundation of America (AAAF) to encourage dialogue with their healthcare provider, and * a certificate of completion for those that attended all three sessions.

Other: Education only

Interventions

The investigators piloted a knowledge and mobile text-messaging intervention using a prospective group design, allocating 14 (asthma=8; COPD=6) and 15 (asthma=9; COPD=6) participants to control and intervention groups respectively, after stratifying by type of disease.

Education (Asthma COPD Workshop) and mobile phone

Participants in the control group only received the educational intervention.

Education only

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Eligible participants for the study were African American adults of 18 years and above.
  • Participants had to have reported physician diagnosed (on the survey distributed at the church) or spirometry diagnosed (at the community health fair) asthma or COPD, access to a text-messaging enabled mobile phone, and provision of signed informed consent.

You may not qualify if:

  • Individuals unwilling to participate in the study and patients with other chronic lung diseases, terminal, or comorbid illnesses more severe in nature than asthma or COPD (i.e., heart disease and cancer) were excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kent State University

Kent, Ohio, 44242, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Interim Associate Dean

Study Record Dates

First Submitted

June 1, 2023

First Posted

March 17, 2025

Study Start

September 1, 2016

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

March 17, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations