Supporting Self-Management of Healthy Behaviors in Chronic Kidney Disease (SMART-HABITS)

• ClinicalTrials.gov Identifier: NCT04858295
• Recruitment Status: Enrolling by invitation
• First Posted: April 26, 2021
• Last Update Posted: January 21, 2022
• Sponsor: University of Pennsylvania
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Information provided by (Responsible Party): University of Pennsylvania

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Renal Insufficiency, Chronic; Hypertension	Device: Texting; Device: mHealth app	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• 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
• Actual Study Start Date: July 26, 2021
• Estimated Primary Completion Date: September 2022
• Estimated Study Completion Date: April 2023

Arms and Interventions

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.	Device: Texting; 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: Way to Health; SMS Text
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.	Device: mHealth app; 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: Omron Connect; Smartphone application

Outcome Measures

Primary Outcome Measures :

1. Feasibility: Adoption [ Time Frame: Collected throughout study (12 weeks) ]
   Composite outcome determined by participant retention rate, total number of assessments performed by participants over complete study period; 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 as measured by data usage statistics.
2. Feasibility: Adherence [ Time Frame: Collected throughout study (12 weeks) ]
   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.
3. Feasibility: Acceptability of mHealth [ Time Frame: 4 weeks, 8 weeks, 12 weeks ]
   Determined through change in pre- and post-study scores on the attitudes toward mHealth questionnaire, entitled Attitudes Toward Mobile Phone-Based Health Monitoring. Answers reported on 5-point Likert scale ranging from 1= strongly disagree, disagree, neither disagree or agree, agree, to 5 = strongly agree, with higher scores indicating better acceptability.
4. Feasibility: Acceptability of SMART-HABITS [ Time Frame: 4 weeks, 8 weeks, 12 weeks ]
   Determined through satisfactory ratings system usability scale survey (score above 68)
5. Feasibility: Acceptability of SMART-HABITS [ Time Frame: 12 weeks ]
   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.

Secondary Outcome Measures :

1. Effectiveness of Education and Empowerment [ Time Frame: 12 weeks ]
   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 as the sum of the correct responses to each survey question divided by the total number of questions, total score range (0-1). Higher scores indicate better knowledge.
2. Effectiveness of Education and Empowerment [ Time Frame: 12 weeks ]
   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. Answers range from 1 = not at all confident to 10= totally confident, with summary scores indicating higher self-efficacy.
3. Effectiveness of Education and Empowerment [ Time Frame: 12 weeks ]
   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 from 0=very good to 8= very poor, with higher summary scores indicating better self-management.
4. Effectiveness of Education and Empowerment [ Time Frame: 12 weeks ]
   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 (range 8-40, with a score of ≥32 considered to be adequate eHealth literacy) or individually (range 1-5), with higher scores indicating better eHealth literacy.
5. Effectiveness of Education and Empowerment [ Time Frame: 12 weeks ]
   Determined by change in pre-pilot and post-pilot scores on responses regarding disease-related quality of life using the Kidney Disease and Quality of Life 36-item survey (KDQOL-36). Scores are reported separately for each of the five KDQOL-36 subscales and as a summary score. Scores are split into tertiles (thirds) based on the mean of the study population: More than one standard deviation above the mean is the "above average" tertile; The mean +/- one standard deviation is "average" tertile; More than one standard deviation below the mean is the "below average" tertile. Higher scores (both sub-scales and summary) indicate better quality of life.
6. Effectiveness of BP Monitoring [ Time Frame: 4, 8, and 12 weeks ]
   Determined by a change in baseline BP (the first BP measure transmitted) compared to mean BP after 4, 8, and 12 weeks
7. Effectiveness of Step Monitoring [ Time Frame: 4, 8, and 12 weeks ]
   Determined by a change in mean step count in first week compared to mean step count after 4, 8, and 12 weeks.
8. Maintenance [ Time Frame: 12 weeks ]
   Determined by the usage of SMART-HABITS. Good maintenance will be determined by at least one access to the SMART-HABITS portal or one BP monitor or step count transmission each week.
9. Implementation Issues [ Time Frame: 12 weeks ]
   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.
10. Reach [ Time Frame: 12 weeks ]
    Determined by the comparison of th sex frequency (percentage) of the enrolled participants compared to sex frequency of general population with chronic kidney disease stage 3 and 4 with hypertension in the United States.
11. Reach [ Time Frame: 12 weeks ]
    Determined by the comparison of race (Black, White other) frequency (percentage) of the enrolled participants compared to the race frequencies of the general population with chronic kidney disease stage 3 and 4 with hypertension in the United States.
12. Reach [ Time Frame: 12 weeks ]
    Determined by the comparison of ethnicity (Hispanic, Non-Hispanic) frequency (percentage) of the enrolled participants compared to ethnicity frequency of the general population with chronic kidney disease stage 3 and 4 with hypertension in the United States.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, Pennsylvania

Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, United States, 19104

Sponsors and Collaborators

University of Pennsylvania

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

• Principal Investigator: Sarah Schrauben, MD, MSCE; University of Pennsylvania Perelman School of Medicine

More Information

• Responsible Party: University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT04858295
• Other Study ID Numbers: 832097; K23DK118198-03 ( U.S. NIH Grant/Contract )
• First Posted: April 26, 2021
• Last Update Posted: January 21, 2022
• Last Verified: January 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided
• Plan Description: To be determined

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Kidney Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Urologic Diseases