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| ID | Type | Description | Link |
|---|---|---|---|
| K23HL141447 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Ohio State University | OTHER |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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SCD is an inherited disorder of hemoglobin that affects over 100,000 Americans, most of whom live in low-resourced neighborhoods. Acute SCD complications result in 230,000 emergency department visits and $1.5 billion annually in acute-care expenditures. Prior research indicates that increased disease-specific knowledge correlates with improved clinical outcomes in SCD. Thus, targeting strategies to improve disease-specific knowledge is a high priority in the care of individuals with SCD. Significant evidence describes how educational materials, including online educational programs, can be used to increase disease-specific knowledge. In this study, the investigators will evaluate a mobile phone technology intervention based on the prior evidence that technologies can improve SCD-specific knowledge.
Sickle cell disease (SCD) is an inherited blood disorder that affects over 100,000 Americans, an underserved population with low life expectancy and risk for significant and life-threatening medical complications (e.g., stroke). Adults with SCD are overwhelmingly members of socially disadvantaged groups, increasing their risk for disparities in care. Annual health expenditure for individuals with SCD in the United States is about $1.5 billion, primarily from multiple emergency room visits (230,000 visits/year) for management of acute complications. Use of disease-specific knowledge has emerged as a powerful tool to decrease health care utilization. Significant evidence has described how to increase disease-specific knowledge using educational materials, including online educational programs in individuals managing chronic diseases, including SCD. Patient knowledge and use of disease-specific information like evidence-based clinical guidelines has the potential to decrease health care utilization. In 2014, the National Heart, Lung, and Blood Institute (NHLBI) published guidelines for evidence-based management of SCD for health care providers. However, to date, no national strategy has been developed to make these guidelines patient-centered, accessible, and actionable for adults with SCD. Federal Meaningful Use regulations have recommended using health-related technologies to improve patient access to their health information to promote patient engagement. Yet, many adults with SCD are not yet fully engaged in use of health technologies because they are unsure of the best format (e.g., mobile or web-based), leading to a health care technology gap. Mobile health applications (apps) that include patient-centered care guidelines could engage and activate this population given the high use of mobile technologies, potentially closing this health technology gap and improving health outcomes.
Evaluate the feasibility and acceptability of the refined iManage in a pilot study with adults with SCD. The investigators will recruit 50 adults from the population of 250 adults with SCD at the Vanderbilt Meharry Sickle Cell Disease Center of Excellence and the ohio state university comprehensive sickle cell center for a 6-month pilot study to evaluate usability, acceptance, and usage. At the end of the study, the investigators will conduct interviews with a subset of participants to gain an in-depth understanding of usage patterns and how to sustain engagement to promote ongoing app use.
Evaluate the efficacy of the refined iManage app on SCD-specific knowledge. The investigators will test the hypothesis that the refined iManage will increase SCD-specific knowledge by measuring SCD-specific knowledge at the start and end of the 6-month pilot study. the investigators will conduct exploratory analyses of secondary outcomes including patient activation, adherence to guidelines, missed days of school/work, and self-efficacy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group (Booklets) | No Intervention | Group 1 will receive the control arm with a paper booklet of the patient-centered SCD-guidelines with education by a health care provider at a single visit | |
| mobile health application | Active Comparator | Group 2 will receive continuous access to technology-based patient-centered SCD-specific guidelines using a user-driven technological platform, plus a paper booklet of the guidelines with education by a health care provider at a single visit. The mobile app will include interactive content and a fully searchable collection of the SCD-specific guidelines that are age- and health literacy-appropriate. Through the mobile app, the investigators will reinforce important points of guideline content; motivate patient engagement through quizzes and reminders; and facilitate peer support, for instance by forming teams to compete against each other to attain goals. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mobile health application | Other | The user-driven technological tool will include an mHealth mobile phone application. Features of the application will be based on preliminary work from the investigators' sites. The mobile app will include fully searchable provider-facing and patient-facing interfaces with the SCD-specific guidelines. The provider-facing interface, designed to be used by providers, will be separated by patient's age to accommodate pediatric and adult providers. The patient-facing interface will display the guidelines that are age- and health literacy-appropriate. Through the mobile app, the investigators will reinforce important points of guideline content; motivate patient engagement through quizzes and text-message reminders; and facilitate peer support, for instance by forming teams to compete against each other to attain goals. |
| Measure | Description | Time Frame |
|---|---|---|
| SCD-specific Knowledge | Knowledge about SCD. This is a questionnaire that is multiple choice and asks questions about sickle cell disease with one correct answer and 3 incorrect answers. The investigators will sum up the number of correct answers which will be reported. There were a total of 39 questions, so a maximum score of 39. This is not a scale. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Self-efficacy | sickle cell self-efficacy scale, as described in Edwards R, Telfair J, Cecil H, Lenoci J. Reliability and validity of a self-efficacy instrument specific to sickle cell disease. Behav Res Ther. 2000;38(9):951-63. Scale is 0-45, higher score is better Scale has no subscales and measures self-efficacy | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University Medical Center | Columbus | Ohio | 43212 | United States | ||
| Vanderbilt University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37595029 | Background | Cronin RM, Quaye N, Liu X, Landes K, Crosby LE, Kassim AA, Volanakis EJ, Schnell PM, DeBaun MR. A feasibility randomized controlled trial of an mHealth app vs booklets for patient-facing guidelines in adults with SCD. Blood Adv. 2023 Oct 24;7(20):6184-6190. doi: 10.1182/bloodadvances.2023010676. |
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We conducted a feasibility randomized controlled trial at two centers: Vanderbilt University Medical Center and the Ohio State University, between 2018-2022. The IRBs approved the trial at each institution. Participants were recruited from sickle cell medical clinics.
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Group (Booklets) | Group 1 will receive the control arm with a paper booklet of the patient-centered SCD-guidelines with education by a health care provider at a single visit |
| FG001 | Mobile Health Application | Group 2 will receive continuous access to technology-based patient-centered SCD-specific guidelines using a user-driven technological platform, plus a paper booklet of the guidelines with education by a health care provider at a single visit. The mobile app will include interactive content and a fully searchable collection of the SCD-specific guidelines that are age- and health literacy-appropriate. Through the mobile app, the investigators will reinforce important points of guideline content; motivate patient engagement. mobile health application: The user-driven technological tool will include an mHealth mobile phone application. Features of the application will be based on preliminary work from the investigators' sites. The mobile app will include fully searchable provider-facing and patient-facing interfaces with the SCD-specific guidelines. The provider-facing interface, designed to be used by providers, will be separated by patient's age to accommodate pediatric and adult providers. The patient-facing interface will display the guidelines that are age- and health literacy-appropriate. Through the mobile app, the investigators will reinforce important points of guideline content; motivate patient engagement through quizzes and text-message reminders; and facilitate peer support, for instance by forming teams to compete against each other to attain goals. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Group (Booklets) | Group 1 will receive the control arm with a paper booklet of the patient-centered SCD-guidelines with education by a health care provider at a single visit |
| BG001 | Mobile Health Application |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | SCD-specific Knowledge | Knowledge about SCD. This is a questionnaire that is multiple choice and asks questions about sickle cell disease with one correct answer and 3 incorrect answers. The investigators will sum up the number of correct answers which will be reported. There were a total of 39 questions, so a maximum score of 39. This is not a scale. | Posted | Median | Inter-Quartile Range | score on a scale | 6 months |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control Group (Booklets) | Group 1 will receive the control arm with a paper booklet of the patient-centered SCD-guidelines with education by a health care provider at a single visit |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Robert Cronin | The Ohio State University | 6146889220 | robert.cronin@osumc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 20, 2023 | Nov 14, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000755 | Anemia, Sickle Cell |
| ID | Term |
|---|---|
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
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Randomized controlled trial
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|
| Healthcare Utilization (ER Visits and Hospitalizations) |
The investigators will measure a count of the # ER visits and # of hospitalizations (i.e., # ER visits + # hospitalizations) |
| 6 months |
| Usage and Usability of the mHealth Application | How often app and functionality was used. Usability will be measured by the widely used and validated System Usability Scale as described in Brooke J. SUS-A quick and dirty usability scale. Usability evaluation in industry. 1996;189(194):4-7. The mobile health application for the guidelines has built-in tracking of the number of times the application is launched, how many times each of the functions are used, and how many times each button has been pushed. To measure usage, the investigators will record the numbers of each of these events for each participant. In addition to total use, the investigators will measure usage over time including any use, initial use, periodic use, and sustained use. SUS scale is 0-100, higher score is better. Scale has no subscales and measures usability of the app | 6 months |
| Patient Activation Measure | The Patient Activation Measure (PAM) is a 10-item questionnaire to assesses a patient's knowledge, skills, and confidence in managing their health and healthcare. Response options range from (1) disagree strongly to (4) agree strongly, and an additional "not applicable" option. The sum of responses (excepting non-applicable items) are converted using Insignia Health's proprietary algorithm (that takes into account the specific wording and weighting of each item in the survey) into a final PAM score on a 0-100 scale. Higher PAM scores indicate a greater level of patient activation in managing their health. | 6 months |
| Nashville |
| Tennessee |
| 37203 |
| United States |
Group 2 will receive continuous access to technology-based patient-centered SCD-specific guidelines using a user-driven technological platform, plus a paper booklet of the guidelines with education by a health care provider at a single visit. The mobile app will include interactive content and a fully searchable collection of the SCD-specific guidelines that are age- and health literacy-appropriate.
mobile health application: The user-driven technological tool will include an mHealth mobile phone application. Features of the application will be based on preliminary work from the investigators' sites. The mobile app will include fully searchable provider-facing and patient-facing interfaces with the SCD-specific guidelines. The provider-facing interface, designed to be used by providers, will be separated by patient's age to accommodate pediatric and adult providers. The patient-facing interface will display the guidelines that are age- and health literacy-appropriate. Through the mobile app, the investigators will reinforce important points of guideline content; motivate patient engagement through quizzes and text-message reminders; and facilitate peer support, for instance by forming teams to compete against each other to attain goals.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Sickle cell genotype | Count of Participants | Participants |
|
|
|
| Secondary | Self-efficacy | sickle cell self-efficacy scale, as described in Edwards R, Telfair J, Cecil H, Lenoci J. Reliability and validity of a self-efficacy instrument specific to sickle cell disease. Behav Res Ther. 2000;38(9):951-63. Scale is 0-45, higher score is better Scale has no subscales and measures self-efficacy | Posted | Median | Inter-Quartile Range | score on a scale | 6 months |
|
|
|
| Secondary | Healthcare Utilization (ER Visits and Hospitalizations) | The investigators will measure a count of the # ER visits and # of hospitalizations (i.e., # ER visits + # hospitalizations) | Posted | Median | Inter-Quartile Range | events | 6 months |
|
|
|
| Secondary | Usage and Usability of the mHealth Application | How often app and functionality was used. Usability will be measured by the widely used and validated System Usability Scale as described in Brooke J. SUS-A quick and dirty usability scale. Usability evaluation in industry. 1996;189(194):4-7. The mobile health application for the guidelines has built-in tracking of the number of times the application is launched, how many times each of the functions are used, and how many times each button has been pushed. To measure usage, the investigators will record the numbers of each of these events for each participant. In addition to total use, the investigators will measure usage over time including any use, initial use, periodic use, and sustained use. SUS scale is 0-100, higher score is better. Scale has no subscales and measures usability of the app | Posted | Median | Inter-Quartile Range | score on a scale | 6 months |
|
|
|
| Secondary | Patient Activation Measure | The Patient Activation Measure (PAM) is a 10-item questionnaire to assesses a patient's knowledge, skills, and confidence in managing their health and healthcare. Response options range from (1) disagree strongly to (4) agree strongly, and an additional "not applicable" option. The sum of responses (excepting non-applicable items) are converted using Insignia Health's proprietary algorithm (that takes into account the specific wording and weighting of each item in the survey) into a final PAM score on a 0-100 scale. Higher PAM scores indicate a greater level of patient activation in managing their health. | Posted | Median | Inter-Quartile Range | score on a scale | 6 months |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Mobile Health Application | Group 2 will receive continuous access to technology-based patient-centered SCD-specific guidelines using a user-driven technological platform, plus a paper booklet of the guidelines with education by a health care provider at a single visit. The mobile app will include interactive content and a fully searchable collection of the SCD-specific guidelines that are age- and health literacy-appropriate. Through the mobile app, the investigators will reinforce important points of guideline content; motivate patient engagement. mobile health application: The user-driven technological tool will include an mHealth mobile phone application. Features of the application will be based on preliminary work from the investigators' sites. The mobile app will include fully searchable provider-facing and patient-facing interfaces with the SCD-specific guidelines. The provider-facing interface, designed to be used by providers, will be separated by patient's age to accommodate pediatric and adult providers. The patient-facing interface will display the guidelines that are age- and health literacy-appropriate. Through the mobile app, the investigators will reinforce important points of guideline content; motivate patient engagement through quizzes and text-message reminders; and facilitate peer support, for instance by forming teams to compete against each other to attain goals. | 0 | 37 | 0 | 37 | 0 | 37 |
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| D006425 |
| Hemic and Lymphatic Diseases |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |