Trial Outcomes & Findings for Using Patient-Centered Guidelines in a Technology Platform to Improve Health Care in Adults With Sickle Cell Disease (NCT NCT03629678)
NCT ID: NCT03629678
Last Updated: 2025-01-14
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
67 participants
Primary outcome timeframe
6 months
Results posted on
2025-01-14
Participant Flow
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.
Participant milestones
| Measure |
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
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
37
|
|
Overall Study
COMPLETED
|
25
|
31
|
|
Overall Study
NOT COMPLETED
|
5
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Using Patient-Centered Guidelines in a Technology Platform to Improve Health Care in Adults With Sickle Cell Disease
Baseline characteristics by cohort
| Measure |
Control Group (Booklets)
n=25 Participants
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
n=31 Participants
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.
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
25 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
30.8 years
STANDARD_DEVIATION 8.82 • n=5 Participants
|
35.6 years
STANDARD_DEVIATION 10.9 • n=7 Participants
|
33.5 years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
24 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
23 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=5 Participants
|
31 participants
n=7 Participants
|
56 participants
n=5 Participants
|
|
Sickle cell genotype
Hemoglobin SS / Sbeta0 thalassemia
|
14 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Sickle cell genotype
Hemoglobin SC / Sbeta+ thalassemia
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Sickle cell genotype
Don't know
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsKnowledge 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.
Outcome measures
| Measure |
Control Group (Booklets)
n=24 Participants
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
n=26 Participants
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.
|
|---|---|---|
|
SCD-specific Knowledge
6-month follow up
|
33.5 score on a scale
Interval 16.0 to 37.0
|
33 score on a scale
Interval 22.0 to 39.0
|
|
SCD-specific Knowledge
Baseline
|
32.0 score on a scale
Interval 12.0 to 37.0
|
32.0 score on a scale
Interval 18.0 to 37.0
|
SECONDARY outcome
Timeframe: 6 monthssickle 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
Outcome measures
| Measure |
Control Group (Booklets)
n=24 Participants
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
n=26 Participants
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.
|
|---|---|---|
|
Self-efficacy
|
34.5 score on a scale
Interval 27.0 to 37.0
|
32.5 score on a scale
Interval 27.2 to 36.0
|
SECONDARY outcome
Timeframe: 6 monthsThe investigators will measure a count of the # ER visits and # of hospitalizations (i.e., # ER visits + # hospitalizations)
Outcome measures
| Measure |
Control Group (Booklets)
n=24 Participants
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
n=26 Participants
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.
|
|---|---|---|
|
Healthcare Utilization (ER Visits and Hospitalizations)
|
0 events
Interval 0.0 to 1.0
|
0 events
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: 6 monthsHow 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
Outcome measures
| Measure |
Control Group (Booklets)
n=26 Participants
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
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.
|
|---|---|---|
|
Usage and Usability of the mHealth Application
|
56.2 score on a scale
Interval 50.0 to 68.8
|
—
|
SECONDARY outcome
Timeframe: 6 monthsThe 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.
Outcome measures
| Measure |
Control Group (Booklets)
n=24 Participants
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
n=26 Participants
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.
|
|---|---|---|
|
Patient Activation Measure
|
73.8 score on a scale
Interval 58.5 to 100.0
|
73.8 score on a scale
Interval 56.0 to 85.3
|
Adverse Events
Control Group (Booklets)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Mobile Health Application
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place