Clinical trial NCT05565716: Supporting Self-Management of Healthy Behaviors in Diabetes, Kidney Disease, and Hypertension
Official title: Supporting Self-Management of Healthy Behaviors Among People With Diabetes, Kidney Disease, and Hypertension (SMART-HABITS-4-Health): A Pilot Trial of a Blood Pressure Monitoring Intervention Leveraging Social Incentives and Gamification
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Insufficiency, Chronic
Hypertension
Diabetes
Keywords: social incentive
gamification
mHealth
self-management
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2022-10-04
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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, 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 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 BP self-monitoring at least 5 times per week, transmit the BP 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 BP 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 BP 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 SBP 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.

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.

Primary outcomes:
measure: Feasibility: Adoption
timeFrame: Collected throughout study (8 weeks)
measure: Feasibility: Adherence
timeFrame: Collected throughout study (8 weeks)
measure: Feasibility: Acceptability of SMART-HABITS-4-Health
timeFrame: collected at 4 weeks
measure: Feasibility: Acceptability of SMART-HABITS-4-Health
timeFrame: collected at 8 weeks
measure: Feasibility: Acceptability of SMART-HABITS-4-Health
timeFrame: Collected with 12 weeks of study completion
Secondary outcomes:
measure: Social Incentive Effectiveness
timeFrame: 8 weeks
measure: CKD Knowledge
timeFrame: 8 weeks
measure: Self-Efficacy
timeFrame: 8 weeks
measure: Chronic Disease Self-Management
timeFrame: 8 weeks
measure: Disease Related Quality of Life
timeFrame: 8 weeks
measure: Maintenance
timeFrame: 8 weeks
measure: Implementation Issues
timeFrame: 8 weeks
measure: Reach
timeFrame: 8 weeks
measure: Reach
timeFrame: 8 weeks
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: