Supporting Self-Management of Healthy Behaviors in Chronic Kidney Disease

NCT04858295 | Completed Results DMC

• 2 other identifiers: 832097K23DK118198-03
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Insufficiency, Chronic; Hypertension

Outcome Measures

Primary Outcomes (4)

• Feasibility: Adoption

  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.

  Collected throughout study (12 weeks)

• Feasibility: Adherence

  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.

  Collected throughout study (12 weeks)

• Feasibility: Change in Acceptability of mHealth From Baseline (Pre-study) and 12 Weeks (Post-study)

  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

• Feasibility: Acceptability of SMART-HABITS

  Determined through satisfactory ratings on the System Usability Scale Survey (range is 0-100 with score above 68 considered adequate usability).

  4 weeks, 8 weeks, 12 weeks

Secondary Outcomes (12)

• Change in CKD Knowledge Scores From Baseline (Pre-study) and 12 Weeks (Post-study)

  12 weeks

• Change in Self-Efficacy of Managing Chronic Disease Scores From Baseline (Pre-study) and 12 Weeks (Post-study)

  12 weeks

• Change in Self-Management Scores From Baseline (Pre-study) and 12 Weeks (Post-study)

  12 weeks

• Change in eHealth Literacy Scores From Baseline (Pre-study) and 12 Weeks (Post-study)

  12 weeks

• Change in Kidney Disease Quality of Life From Baseline (Pre-study) and 12 Weeks (Post-study)

  12 weeks

Study Arms (2)

Texting Arm

ACTIVE COMPARATOR

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.

Device: Texting

mHealth app Arm

ACTIVE COMPARATOR

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.

Device: mHealth app

Interventions

Texting DEVICE

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.

Also known as: Way to Health, SMS Text

Texting Arm

mHealth app DEVICE

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.

Also known as: Omron Connect, Smartphone application

mHealth app Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pennsylvania: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• Schrauben SJ, Park D, Amaral S, Purcell A, Zhang S, Kearney M, Bilger A, Feldman HI, Dember LM. Supporting Self-Management of Healthy Behaviors in Chronic Kidney Disease and Hypertension: The Supporting Self-Management of Healthy Behaviors Pilot Randomized Trial. Clin J Am Soc Nephrol. 2024 Sep 1;19(9):1109-1118. doi: 10.2215/CJN.0000000000000492. Epub 2024 Jul 2.

  PMID: 38954482 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Hypertension

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Dr. Sarah Schrauben
• Organization: University of Pennsylvania

sarahsch@upenn.edu

267-324-7588

Study Officials

• Sarah Schrauben, MD, MSCE

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2021
• First Posted: April 26, 2021
• Study Start: July 26, 2021
• Primary Completion: June 30, 2022
• Study Completion: May 1, 2023
• Last Updated: November 17, 2025
• Results First Posted: April 9, 2024

Record last verified: 2025-10

Locations

US (1)