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OpenTrials
Completed

NCT Number: NCT06878898

Impact of a Mobile Phone and Educational Intervention

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.

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Key information

Conditions

Pulmonary Disease, Chronic Obstructive Asthma COPD Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kent State University

Kent, Ohio, 44242, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Education and mobile phone text-messaging

Behavioral

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 only

Other

Participants in the control group only received the educational intervention.

Primary outcomes

  1. Disease Knowledge: Knowledge and Management Questionnaire

    Time frame: Baseline, 3 months after ACOPD workshop, 9-months post-ACOPD workshop

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

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

    Time frame: Baseline, 3 months after ACOPD workshop, 9-months post-ACOPD workshop

    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.

  3. Health-related quality of life in participants with Asthma

    Time frame: Baseline, 3 months after ACOPD workshop, 9-months post-ACOPD workshop

    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.

Secondary outcomes

  1. Respiratory management behaviors

    Time frame: Baseline, 3 months after ACOPD workshop, 9-months post-ACOPD workshop

    Respiratory Management Behaviors Questionnaire (RMBQ) at baseline: A study-developed questionnaire with 27 items and were summarized as frequencies and proportions.

  2. Self-efficacy

    Time frame: Baseline, 3 months after ACOPD workshop, 9-months post-ACOPD workshop

    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.

Sponsors and collaborators

Lead sponsor

Kent State University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 17, 2025
Registry last updated
Mar 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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