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Clinical Trials/NCT06878898
NCT06878898CompletedNot Applicable

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

Kent State University1 site in 1 country29 target enrollmentStarted: September 1, 2016Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
29
Locations
1
Primary Endpoint
Disease Knowledge: Knowledge and Management Questionnaire

Study Overview

Brief Summary

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.

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Screening
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Arms & Interventions

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.

Intervention: Education and mobile phone text-messaging (Behavioral)

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.

Intervention: Education only (Other)

Outcomes

Primary Outcomes

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

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.

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

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Melissa Zullo

Professor and Interim Associate Dean

Kent State University

Study Sites (1)

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