Clinical trial NCT04858295: Supporting Self-Management of Healthy Behaviors in Chronic Kidney Disease
Official title: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Insufficiency, Chronic
Hypertension
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2021-04-26
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The pilot cross-over study aims to examine the feasibility of a smartphone-based self-management supportive intervention, Supporting Self-Management of Healthy Behaviors (SMART-HABITS) in patients with chronic kidney disease (CKD) and hypertension. SMART-HABITS is a web-based application accessible on any device that has Internet access and utilizes a mobile health research platform (Way to Health) that links to wearable sensor smartphone applications such as FitBit and Omron Connect, to provide reminders, tailored feedback, and provide access to educational resources, and to community resources. The cross-over design is used to test preferences of using text message or a smartphone app to communicate blood pressure readings.

Detailed description: The pilot study aims to examine the feasibility, as measured by adoption, adherence, and acceptance, of a smartphone-based self-management supportive intervention, Supporting Self-Management of Healthy Behaviors (SMART-HABITS) in patients with chronic kidney disease (CKD) and hypertension. SMART-HABITS is a web-based application accessible on any device that has Internet access and utilizes the mobile health research platform to provide the components of the intervention: a) text message reminders (Arm 1), b) text message tailored feedback (Arm 1 and 2), c) positive affirmation text messages (Arms 1 and 2), d) access to educational resources, community resources, CKD patient forums (Arms 1 and 2), e) option to select a accountability partner to share reminders and feedback (Arms 1 and 2). SMART-HABITS encompasses multiple behavior change techniques and is centered on the Health Belief Model and the Social Cognitive Theory. SMART-HABITS will deliver reminder text messages to a participant's smartphone to perform blood pressure self-monitoring in one arm and encourage an increase in walking activity both arms. The Omron Connect app will deliver the reminder notifications to check blood pressure and will deliver the BP readings to research platform (in the non-texting arm). After blood pressure measurements and daily step counts are remotely transmitted from the smartphone to mobile health research platform server, tailored feedback will be provided via text message). Additionally, intermittent positive affirmation messages will also be sent to participants to encourage engagement in the behaviors. Within the SMART-HABITS web-based application, there will be a participant portal that will provide access to links to community resources, educational links about CKD, and a display of adherence to behaviors and data transmission. At the beginning and end of the study, questionnaires will be completed to assess patient-reported outcomes, which will serve as secondary endpoints.

Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility: Adoption
timeFrame: Collected throughout study (12 weeks)
measure: Feasibility: Adherence
timeFrame: Collected throughout study (12 weeks)
measure: Feasibility: Change in Acceptability of mHealth From Baseline (Pre-study) and 12 Weeks (Post-study)
timeFrame: 12 weeks
measure: Feasibility: Acceptability of SMART-HABITS
timeFrame: 4 weeks, 8 weeks, 12 weeks
Secondary outcomes:
measure: Change in CKD Knowledge Scores From Baseline (Pre-study) and 12 Weeks (Post-study)
timeFrame: 12 weeks
measure: Change in Self-Efficacy of Managing Chronic Disease Scores From Baseline (Pre-study) and 12 Weeks (Post-study)
timeFrame: 12 weeks
measure: Change in Self-Management Scores From Baseline (Pre-study) and 12 Weeks (Post-study)
timeFrame: 12 weeks
measure: Change in eHealth Literacy Scores From Baseline (Pre-study) and 12 Weeks (Post-study)
timeFrame: 12 weeks
measure: Change in Kidney Disease Quality of Life From Baseline (Pre-study) and 12 Weeks (Post-study)
timeFrame: 12 weeks
measure: Effectiveness of Home Monitoring of BP
timeFrame: 4, 8, and 12 weeks
measure: Effectiveness of Step Monitoring
timeFrame: 4, 8, and 12 weeks
measure: Maintenance
timeFrame: 12 weeks
measure: Implementation Issues
timeFrame: 12 weeks
measure: 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
timeFrame: At the time of randomization
measure: 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
timeFrame: At time of randomization
measure: 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
timeFrame: Enrolled and randomized
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Penn Presbyterian Medical Center
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Sarah Schrauben, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
References: