- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04858295
Supporting Self-Management of Healthy Behaviors in Chronic Kidney Disease (SMART-HABITS)
A Pilot Trial of the Feasibility of a Patient-Centered Mobile Health Self-Management Support Tool for Healthy Behaviors (SMART-HABITS) in Chronic Kidney Disease
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Penn Presbyterian Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- adult patients with hypertension (treated with three or less anti-hypertensive medications) and chronic kidney disease stage 3 or 4 managed in participating nephrology practices
- have a smartphone that they are willing to carry with them the majority of the time while enrolled in the study
- able to comprehend English,
- have ability to walk.
- mean blood pressure of <=180/100 mmHg from historical blood pressure readings in the electronic medical record
- able and willing to provide informed consent
Exclusion Criteria:
- inability to provide consent or read or speak English
- had MI or stroke within the previous six months,
- diagnosis of dementia or cognitive impairment
- inability to walk
- already participating in another physical activity study
- belong to vulnerable population
- likely to receive a kidney transplant within 1 month of enrollment into the trial
- living in a long-term care or rehabilitation institution
- likely to have their care transferred to another facility outside participating clinic areas during the course of the study
- planning to travel or live consecutively out of the country for more than one month
- participating in another intervention trial,
- hypertension not managed by the nephrologist in the clinic
- prescribed more than three anti-hypertensive medications (i.e. resistant hypertension),
- any other reason they do not expect to be able to complete the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Texting Arm
Participants will receive automated text message reminders to check their blood pressure (BP) at least three days per week (participants will choose which days and times to receive reminders).
Participants will transmit BP readings with text message to the Way to Health server.
If a BP reading is not received within 3 hours, another reminder will be sent.
Automated text message feedback will be sent with a tailored message.
Participants will asked to set a daily step goal of at least 3,000 steps per day and transmit their step count information from their FitBit.
Participants will be reminded once a day to sync their FitBit.
Motivating messages will be sent weekly.
After 4 weeks, and 8 weeks of the study, a usability survey will be sent.
Weekly and daily feedback will be sent.
At the conclusion of week 6, individuals will "crossover" and will continue for an additional 6 weeks using the opposite technology to communicate BP readings.
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The Way to Health platform is an automated information technology platform that integrates wireless devices, clinical trial randomization and enrollment processes, messaging (text, e-mail, voice), self-administered surveys, and secure data capture for research purposes.
Way to Health has been used successfully in prior behavior intervention studies.
Other Names:
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Active Comparator: mHealth app Arm
Participants randomized to the mHealth app (Omron Connect) arm will receive reminder messages to check their BP via push notifications from the Omron Connect app at least three times weekly.
Upon receipt of the BP reading to the research platform from Omron Connect, participants will receive automatic tailored text message feedback similar to the texting arm.
Participants will asked to set a daily step goal of at least 3,000 steps per day and transmit their step count information from their FitBit.
Participants will be reminded once a day to sync their FitBit.
Motivating messages will be sent weekly.
After 4 weeks, and 8 weeks of the study, a usability survey will be sent.
Weekly and daily feedback will be sent.
At the conclusion of week 6, individuals will "crossover" and will continue for an additional 6 weeks using the opposite technology to communicate BP readings.
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Omron Connect app available on a participant's smartphone connects to the participant's home Omron blood pressure monitor via bluetooth technology.
The Omron Connect app, which stores the blood pressure readings and provides reminders to the participant via push notifications also communicates with the Way to Health research platform via Internet connection.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility: Adherence
Time Frame: Collected throughout study (12 weeks)
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Determined by the number of blood pressure assessments and step counts performed divided by the number of assessments recommended.
Good adherence will be determined by greater than or equal to 70 percent performed out of the recommended.
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Collected throughout study (12 weeks)
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Feasibility: Acceptability of SMART-HABITS
Time Frame: 12 weeks
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Determined by inductive qualitative analysis from semi-structured interviews with study participants after the end of the pilot study.
There is no a priori set up codes or scales to assess this outcome as it is purely a qualitative outcome.
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12 weeks
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Feasibility: Adoption
Time Frame: Collected throughout study (12 weeks)
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Composite outcome determined by participant retention rate, any use of the SMART-HABITS dashboard; Good adoption will be determined by greater than or equal to 70 percent of those retained in the study, and greater than or equal to 70 percent of those enrolled who actually used SMART-HABITS dashboard/web app as measured by data usage statistics.
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Collected throughout study (12 weeks)
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Feasibility: Change in Acceptability of mHealth From Baseline (Pre-study) and 12 Weeks (Post-study)
Time Frame: 12 weeks
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Determined through change in pre- and post-study scores on the three attitude statements toward mHealth, entitled Attitudes Toward Mobile Phone-Based Health Monitoring. Answers reported on 5-point Likert scale ranging from 1= strongly disagree, 2=disagree, 3=neither disagree or agree, 4=agree, to 5 = strongly agree (total range 3-15), with higher scores indicating better acceptability. If reporting a score on a scale, please include the unabbreviated scale title, the minimum and maximum values, and whether higher scores mean a better or worse outcome. |
12 weeks
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Feasibility: Acceptability of SMART-HABITS
Time Frame: 4 weeks, 8 weeks, 12 weeks
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Determined through satisfactory ratings on the System Usability Scale Survey (range is 0-100 with score above 68 considered adequate usability).
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4 weeks, 8 weeks, 12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Implementation Issues
Time Frame: 12 weeks
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Qualitative reports describing adaptions that were made to the SMART-HABITS program in response to participant feedback, including descriptions of alterations that were made to the schedule of reminders and messaging content.
Participant feedback data will be collected with field notes from verbal conversations and textual data from email and text messages.
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12 weeks
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Change in CKD Knowledge Scores From Baseline (Pre-study) and 12 Weeks (Post-study)
Time Frame: 12 weeks
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Determined by change in pre-pilot and post-pilot scores on responses regarding CKD knowledge using the 28-question Kidney Knowledge Survey (KiKS). The survey score is defined the percentage correct responses to each answered question divided by the total, total range 0-100%. Higher percentages indicate better knowledge. If reporting a score on a scale, please include the unabbreviated scale title, the minimum and maximum values, and whether higher scores mean a better or worse outcome. |
12 weeks
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Change in Self-Efficacy of Managing Chronic Disease Scores From Baseline (Pre-study) and 12 Weeks (Post-study)
Time Frame: 12 weeks
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Determined by change in pre-pilot and post-pilot scores on responses regarding self-efficacy using the Self-Efficacy for Managing Chronic Disease 6-Item Scale.
Answer range from 1 = not at all confident to 10= totally confident, with higher scores indicating higher self-efficacy.
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12 weeks
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Change in Self-Management Scores From Baseline (Pre-study) and 12 Weeks (Post-study)
Time Frame: 12 weeks
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Determined by change in pre-pilot and post-pilot scores on responses regarding self-management using the Partners in Health Scale for Chronic Condition Self-Management (11 items).
Answers range on a linear scale provided: very good=0, 1, 2, 3, 4=satisfactory, 5, 6, 7, 8= very poor.
Total range of scores 0-88, with higher scores indicating better self-management.
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12 weeks
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Change in eHealth Literacy Scores From Baseline (Pre-study) and 12 Weeks (Post-study)
Time Frame: 12 weeks
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Determined by change in pre-pilot and post-pilot scores on responses regarding eHealth literacy Scale (eHEALS).
eHEALS consists of eight questions with 5 response options on a Likert-scale, and scored as a cumulative score of the eight questions (total range 8-40) with higher scores indicating better eHealth literacy (a score of ≥32 is considered to be adequate eHealth literacy).
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12 weeks
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Change in Kidney Disease Quality of Life From Baseline (Pre-study) and 12 Weeks (Post-study)
Time Frame: 12 weeks
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Determined by change in pre-pilot and post-pilot scores on responses regarding disease-related quality of life using the Kidney Disease Quality of Life 36-item survey (KDQOL-36).
Scores are reported separately for each of the three KDQOL-36 subscales: Symptoms and Problems (12 items), Burden of Kidney Disease (4 items), and Effects of Kidney Disease (8 items); all items have 5 response options.
Each sub-scale scores are transformed to 0 to 100 with higher scores indicating better quality of life.
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12 weeks
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Effectiveness of Home Monitoring of BP
Time Frame: 4, 8, and 12 weeks
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Mean systolic blood pressure after 4, 8, and 12 weeks
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4, 8, and 12 weeks
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Effectiveness of Step Monitoring
Time Frame: 4, 8, and 12 weeks
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Mean step count in first week, and after 4, 8, and 12 weeks.
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4, 8, and 12 weeks
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Maintenance
Time Frame: 12 weeks
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Determined by transmitting at least one BP monitored reading or daily step count each week.
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12 weeks
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Reach: Qualitatively Similar Frequency of the Sex Distribution of Participants in the Study at the Time of Randomization vs. Published Information on the US General Population With Chronic Kidney Disease Stage 3 and 4 With Hypertension
Time Frame: At the time of randomization
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Sex frequency of randomized participants compared to the published sex frequency of the US population with CKD (female approximately 55%)
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At the time of randomization
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Reach: Qualitatively Similar Frequency (Percentage) of the Race Group Distribution of Randomized Participants vs. US General Population With Chronic Kidney Disease Stage 3 and 4 With Hypertension
Time Frame: At time of randomization
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Frequency of race groups (Black, White other) of participants at time of randomization compared to the approximate frequency---- of the US population with CKD (black race group = 18%, white race group = 75%)
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At time of randomization
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Reach: Qualitatively Similar Frequency (Percentage) of the Ethnic Group Distribution of Randomized Participants vs. US General Population With Chronic Kidney Disease Stage 3 and 4 With Hypertension
Time Frame: Enrolled and randomized
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Determined by the comparison of ethnicity (Hispanic, Non-Hispanic) frequency (percentage) of the randomized participants compared to ethnicity frequency of the general population with chronic kidney disease stage in the United States (Hispanic = ~13%).
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Enrolled and randomized
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sarah Schrauben, MD, MSCE, University of Pennsylvania
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 832097
- K23DK118198-03 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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