ClinicalTrials.gg
CompletedNCT06878898Updated Mar 17, 2025

Impact of a Mobile Phone and Educational Intervention

An interventional study of Education and mobile phone text-messaging and Education only in Pulmonary Disease, Chronic Obstructive and Asthma COPD, sponsored by Kent State University. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-17.

Sponsored by Kent State University · Not applicable, Interventional, and Screening

From the registry’s dates

  • Registered 6 years 9 months after the study started (first participant enrolled Sep 2016, registered Jun 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
29
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Pulmonary Disease, Chronic Obstructive
  • Asthma COPD
03

In context

Pulmonary Disease, Chronic Obstructive

5,520 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 856 are open to participants now.

This study's enrollment of 29 is below the median of 62 across 3,839 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.

Browse Pulmonary Disease, Chronic Obstructive studies →

Lead sponsor

Kent State University is the lead sponsor of 33 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 , access to a text-messaging enabled mobile phone, and provision of signed .

Exclusion criteria

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 (i.e., heart disease and cancer) were excluded from the study.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
29 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • BehavioralEducation 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.

  • OtherEducation only

    Participants in the control group only received the educational intervention.

06

What researchers measure

Primary outcomes

  1. Disease Knowledge: Knowledge and Management Questionnaire

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

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

  2. 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.

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

  3. 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.

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

Secondary outcomes

  1. Respiratory management behaviors

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

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

  2. 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.

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

07

Study locations

1 site
  • Kent State University
    Kent, Ohio 44242, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2016 to primary completion in Apr 2017, 7 months.

Of 1,094 non-industry interventional studies with no phase under Pulmonary Disease, Chronic Obstructive, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's 7 months is below that.

Counting every sponsor, half of 1,181 studies reached it within 22 months; a quarter within 10 and three quarters within 39.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 1, 2023
First posted
Mar 17, 2025
StartActual
Sep 2016
Primary completionActual
Apr 2017
CompletionActual
Apr 2017
Last update
Mar 17, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06878898
Lead sponsor
Kent State University
Responsible party
Melissa Zullo (Professor and Interim Associate Dean, Kent State University) — Principal investigator
First posted
Mar 17, 2025
Start date
Sep 2016
Primary completion
Apr 2017
Completion
Apr 2017
Last update
Mar 17, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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