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

NCT05565716 | Completed DMC

• 2 other identifiers: 851515K23DK118198
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Insufficiency, Chronic; Hypertension; Diabetes

Keywords

social incentive; gamification; mHealth; self-management

Outcome Measures

Primary Outcomes (5)

• Feasibility: Adoption

  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-4-Health at least one time as measured by data usage statistics.

  Collected throughout study (8 weeks)

• Feasibility: Adherence

  Determined by the number of blood pressure assessments 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 (8 weeks)

• Feasibility: Acceptability of SMART-HABITS-4-Health

  Determined through satisfactory ratings system usability scale survey (score above 68)

  collected at 4 weeks

• Feasibility: Acceptability of SMART-HABITS-4-Health

  Determined through satisfactory ratings system usability scale survey (score above 68)

  collected at 8 weeks

• Feasibility: Acceptability of SMART-HABITS-4-Health

  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.

  Collected with 12 weeks of study completion

Secondary Outcomes (9)

• Social Incentive Effectiveness

  8 weeks

• CKD Knowledge

  8 weeks

• Self-Efficacy

  8 weeks

• Chronic Disease Self-Management

  8 weeks

• Disease Related Quality of Life

  8 weeks

Study Arms (2)

Support Person

EXPERIMENTAL

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.

Other: Support Person

Social Norms

EXPERIMENTAL

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.

Other: Social Norms

Interventions

Support Person 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.

Also known as: Social Support, Peer Mentor

Support Person

Social Norms 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.

Also known as: comparative information, normative feedback

Social Norms

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

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

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Hypertension; Diabetes Mellitus

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; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Sarah Schrauben, MD, MSCE

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2022
• First Posted: October 4, 2022
• Study Start: August 21, 2023
• Primary Completion: January 31, 2025
• Study Completion: March 31, 2025
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)