Supporting Self-Management of Healthy Behaviors in Diabetes, Kidney Disease, and Hypertension

NCT ID: NCT05565716

Last Updated: 2025-12-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-21
• Study Completion Date: 2025-03-31

Brief Summary

The planned intervention, entitled, Supporting Self-Management of Health Behaviors to Optimize Health (SMART-HABITS for Health), aims to provide support for patients with chronic kidney disease (CKD), hypertension and diabetes by providing text messages delivered as motivational reminders and support to encourage blood pressure self-monitoring through goal setting, customized task prompts via text message and feedback, leveraging social connections, and use of a gamification design.

Detailed Description

The pilot trial is designed to study the feasibility of a smartphone-based behavioral intervention in a two groups of participants diagnosed with chronic kidney disease (CKD), diabetes, and hypertension. The patients will be identified for eligibility by screening the scheduled for follow up appointments in the Penn renal CKD clinics. Patients will be prospectively enrolled after informed consent. Participants will be prospectively enrolled and will be randomized to participate into one of two arms.

• Arm 1: Social Support - the participant's performance shared with an identified personal support person, such as a friend or a family member or a Peer Mentor; the support person is encouraged to support the participant on at least a weekly basis. Prior to randomization, each participant will select their preference of a personal support personal or a Peer Mentor. A Peer Mentor is a person also with CKD, HTN, and diabetes who has successfully incorporated regular blood pressure monitoring into their lives.
• Arm 2: Social norms -Participants will have access to a leaderboard of all people in the study that shows blood pressure performance information (frequency and control). They will also receive weekly feedback regarding their personal blood pressure performance, compare to their individualized goals and from the preceding week.

All participants will receive text message reminders sent to prompt blood pressure self-monitoring at least 5 times per week, transmit the blood pressure readings to the secure Way to Health server via Omron Connect app. If a blood pressure reading is not received within 5 hours, another reminder will be sent. Automated text message feedback will be sent after the blood pressur reading is recorded with a tailored message regarding any further required actions based upon the BP readings obtained. Any participant with a single systolic blood pressure reading 200mmHg or two consecutive systolic blood pressure readings 180 mmHg or diastolic blood pressure readings 110 mmHg will be contacted immediately by an MD (Dr. Schrauben) for assessment (including evaluation for symptoms of hypertensive emergency) and referral to the emergency department, if indicated. Please see full text message algorithm (attached protocol). Any participant will undergo re-engagement protocol for low participation.

To further support behavior engagement, there is a gamification element to the design:

• At the beginning of each week (Monday), all participants will receive 70 points (10 points for each day of the week). If participants do not send a BP each day, they will lose 10 points. The goal is to check blood pressure at least 4 days per week.
• All participants will start the study at the second of five levels. At week's end (Sunday), if a participant has ≥40 points, their average systolic blood pressure was in their individualized controlled goal, or their average BP declined from the week prior, they will move up a level to acknowledge goal attainment and improvement, and if not, they will drop a level.
• If a participant reaches the 4th level out of five, they will receive a digital trophy. At study's end, if they accumulate ≥5 trophies, they will receive a mug.
• If a participant reaches the 5th level, they will receive a digital medal. At study's end, if they accumulate ≥4 medals, they will receive a tote bag.
• Each week, participants will receive 50 points to leverage "fresh-start effect"

At the end of the study, each participant will be invited to participate in focus groups for additional feedback on their experience.

Conditions

Renal Insufficiency, Chronic; Hypertension; Diabetes

Keywords

social incentive; gamification; mHealth; self-management

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Support Person

A support person not in the study will receive the participant's weekly blood pressure performance details and will contact them at least on a weekly basis to encourage continued blood pressure monitoring. Prior to randomization, the participant will select a preference between a support person that is close to them (e.g., friend or family member) or a support person who is provided by the study, a Peer Mentor.

Group Type: EXPERIMENTAL

Support Person

Intervention Type: OTHER

Prior to randomization, participants will select their preference of the type of support person if they are assigned to this arm 1) a person they have close relationship with, or 2) a Peer Mentor, an individual who has successfully monitored their blood pressure at home using the study's equipment and also has diabetes, kidney disease, and high blood pressure. The Peer Mentor works with the research study team.

This will be provided with the same weekly blood pressure feedback that the participants will receive. The support person is encouraged to reach out to the participant at least weekly.

Social Norms

In this arm, participants will be texted reports of blood pressure performance statistics of the other participants in the study and also receive weekly feedback about how their blood pressure information compares to others in the study. Participants in this arm will have access to a leaderboard that displays this information.

Group Type: EXPERIMENTAL

Social Norms

Intervention Type: OTHER

Participants will receive weekly text messages that includes their individualize blood pressure performance statistics, included frequency of blood pressure monitoring and average blood pressure, and compare it to goals provided at the beginning of the study, as well as the week prior. Participants will also has access to a leaderboard that displays blood pressure performance information all people in the study in an anonymous fashion.

Interventions

Support Person

Prior to randomization, participants will select their preference of the type of support person if they are assigned to this arm 1) a person they have close relationship with, or 2) a Peer Mentor, an individual who has successfully monitored their blood pressure at home using the study's equipment and also has diabetes, kidney disease, and high blood pressure. The Peer Mentor works with the research study team.

This will be provided with the same weekly blood pressure feedback that the participants will receive. The support person is encouraged to reach out to the participant at least weekly.

Intervention Type: OTHER

Social Norms

Participants will receive weekly text messages that includes their individualize blood pressure performance statistics, included frequency of blood pressure monitoring and average blood pressure, and compare it to goals provided at the beginning of the study, as well as the week prior. Participants will also has access to a leaderboard that displays blood pressure performance information all people in the study in an anonymous fashion.

Intervention Type: OTHER

Other Intervention Names

Social Support; Peer Mentor; comparative information; normative feedback

Eligibility Criteria

Inclusion Criteria

• diagnosis of chronic kidney disease (any stage), hypertension, diabetes
• followed at University of Pennsylvania nephrology practice
• aged 18 years or over. -
• own a smart device (smartphone or tablet) capable of connecting to the internet and has Bluetooth enabled technology
• able to comprehend English.
• a mean blood pressure reading of <180/100 mmHg in person study visit
• able and willing to provide informed consent

Exclusion Criteria

• inability to provide consent or read or speak English
• inability to self-monitor (e.g., diagnosis of dementia, cognitive impairment, physically unable to set up BP cuff and machine)
• already participating in another blood pressure study or intervention trial
• vulnerable populations, living in a long-term care or rehabilitation institution,
• if 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
• mean blood pressure reading of >180/100 mmHg at in person study visit
• hypertension not managed by the nephrologist in Penn Medicine
• any other reason they do not expect to be able to complete the study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

NIH

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sarah Schrauben, MD, MSCE

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

K23DK118198

Identifier Type: NIH

Identifier Source: secondary_id

View Link

851515

Identifier Type: -

Identifier Source: org_study_id