Impact of a Mobile Phone and Educational Intervention

Impact of a Mobile Phone and Educational Intervention on Health-related Quality of Life and Health Behaviors of African Americans With Asthma or COPD

The purpose of this pilot study was to:

1. partner with African American churches to increase awareness of COPD.
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. 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.

The study used a randomized controlled trial (RCT) design to assess the effect of the intervention (education and mobile text-messaging) on health-related quality of life and health behaviors recommended for improved COPD self-management. All participants received the educational component then were randomized to a control group and intervention group, in which participants received mobile phone-based text messages on improving health behaviors associated with better self-management of asthma and COPD.

Study Overview

• Status: Completed
• Conditions: Pulmonary Disease, Chronic Obstructive; Asthma COPD
• Intervention / Treatment: Behavioral: Education and mobile phone text-messaging; Other: Education only

Detailed Description

This pilot study evaluated the feasibility and impact of a combined intervention on HRQOL and three health behaviors (nutrition, physical activity, avoiding triggers) in African Americans with asthma or COPD. This was a community-based intervention that recruited participants from six predominantly African American churches. African Americans over 18 years with asthma or COPD were randomized to control or intervention. Intervention received education (asthma COPD (ACOPD) Program) and a one-month text-messaging program, while control received the ACOPD Program alone. Measures were made at three- and 9-month follow-up. Independent and paired t-tests were used to examine HRQOL between groups and over time.

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Kent, Ohio, United States, 44242
      • Kent State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Education (Asthma COPD Workshop) and mobile phone; 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; 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.
Active Comparator: Education only; 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; Participants in the control group only received the educational intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Respiratory management behaviors	Respiratory Management Behaviors Questionnaire (RMBQ) at baseline: A study-developed questionnaire with 27 items and were summarized as frequencies and proportions.	Baseline, 3 months after ACOPD workshop, 9-months post-ACOPD workshop
Self-efficacy	Self-Efficacy Questionnaire (SEQ) at baseline: The Self-Efficacy Questionnaire with 6-items from a combination of self-efficacy scales developed for chronic illness. The scale ranges from 1-10 and higher scores indicate higher self-efficacy.	Baseline, 3 months after ACOPD workshop, 9-months post-ACOPD workshop

Collaborators and Investigators

• Sponsor: Kent State University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: June 1, 2023
• First Submitted That Met QC Criteria: March 12, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 12, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Pulmonary Disease, Chronic Obstructive; Asthma
• Other Study ID Numbers: 16-061

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No