Pulmonary Disease, Chronic ObstructiveNCT06878898
Impact of a Mobile Phone and Educational Intervention
A study testing Education and mobile phone text-messaging and Education only in people with Pulmonary Disease, Chronic Obstructive and Asthma COPD, run by Kent State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive, Asthma COPD
- What is being tested?
- Education and mobile phone text-messaging and Education only
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
The purpose of this pilot study was to:
- partner with African American churches to increase awareness of COPD.
- 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.
- 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.
- Being tested
- Education and mobile phone text-messaging, Education only
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education and mobile phone text-messagingBehavioural
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 onlyOther
Participants in the control group only received the educational intervention.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Education only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Knowledge: Knowledge and Management Questionnaire
Disease Knowledge: A knowledge questionnaire on basic disease concepts and management practices
Measured: 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.
Measured: 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.
Measured: Baseline, 3 months after ACOPD workshop, 9-months post-ACOPD workshop
Secondary outcomes (2)
Respiratory management behaviors
Respiratory Management Behaviors Questionnaire (RMBQ) at baseline: A study-developed questionnaire with 27 items and were summarized as frequencies and proportions.
Measured: 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.
Measured: Baseline, 3 months after ACOPD workshop, 9-months post-ACOPD workshop
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2025
- Study startSep 2016
- Primary completionApr 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kent State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melissa Zullo, Kent State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06878898
- Sponsor's protocol ID
- 16-061
- Status last verified
- Mar 2025
- First submitted
- 1 Jun 2023
- Last updated
- 17 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06878898
- Acronym / sponsor ID
- 16-061
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Kent State UniversityUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 17 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this pilot study was to:
- partner with African American churches to increase awareness of COPD.
- 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.
- 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
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Education (Asthma COPD Workshop) and mobile phone | Experimental | Behavioral: Education and mobile phone text-messagingThe 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. |
| Education only | Active comparator | Other: Education onlyThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Education and mobile phone text-messagingThe 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. | Behavioural | Education (Asthma COPD Workshop) and mobile phone |
| Education onlyParticipants in the control group only received the educational intervention. | Other | Education only |
Primary outcome
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.
2 secondary outcomes
Respiratory management behaviors
Time frame: Baseline, 3 months after ACOPD workshop, 9-months post-ACOPD workshop
Self-efficacy
Time frame: Baseline, 3 months after ACOPD workshop, 9-months post-ACOPD workshop
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education and mobile phone text-messaging and Education only in people with Pulmonary Disease, Chronic Obstructive and Asthma COPD, run by Kent State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease Knowledge: Knowledge and Management Questionnaire (time frame: Baseline, 3 months after ACOPD workshop, 9-months post-ACOPD workshop). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2025.