Diabetes, Hypertension, Renal Insufficiency, Chronic
Conditions
Keywords
social incentive, gamification, mHealth, self-management
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.
Interventions
OTHERSupport 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.
OTHERSocial 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.
Sponsors
University of Pennsylvania
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility: Adoption | Collected throughout study (8 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-4-Health at least one time as measured by data usage statistics. |
| Feasibility: Adherence - Number of Participants Completed 70% or More Blood Pressure Measurements | Collected throughout study (8 weeks) | Participants reported represent participants with good adherence, which was determined by 70% or more of the blood pressure assessments throughout the study period out of the recommended. |
| Feasibility: Acceptability of SMART-HABITS-4-Health | collected at 4 weeks | Determined through satisfactory score on the System Usability Scale survey (defined as a score above 68). Survey range is 0-100, with higher scores indicating more usability and acceptability. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Social Incentive Effectiveness | 8 weeks | Mean change in baseline blood pressure (the baseline visit BP) to mean blood pressure after 8 weeks in both arms. |
| CKD Knowledge | 8 weeks | Determined by change in enrollment survey and end of study survey 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. |
| Self-Efficacy | 8 weeks | Determined by change in enrollment survey and end of study survey 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. Total summary score range is 6-60, with higher summary scores indicating higher self-efficacy. |
| Chronic Disease Self-Management | 8 weeks | Determined by change in enrollment survey and end of study survey 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 for each of the 11 items. Total summary score range is 0-88, with higher summary scores indicating better self-management. |
| Disease Related Quality of Life Change Scores | 8 weeks | Change from baseline to end of study in disease-specific quality of life as measured by the Kidney Disease and Quality of Life 36-item survey (KDQOL-36), a validated instrument assessing health-related quality of life in individuals with kidney disease. The KDQOL-36 includes kidney disease-specific sub scales: Burden of Kidney Disease, Symptoms and Problems, and Effects of Kidney disease on Daily Life. Raw scores are transformed to T-scores, standardized to a general population reference with a mean of 50 and standard deviation of 10. For all sub-scales, higher T-scores indicate better health-related quality of life (i.e., lower symptom burden and less impact of kidney disease), while lower scores indicate worse quality of life. Scores are reported separately by each domain. A change of approximately 5 points is generally considered clinically meaningful in kidney disease populations. |
| Maintenance | 8 weeks | Determined by the usage of SMART-HABITS-4-Health. Good maintenance will be determined by at least one access to the SMART-HABITS-4-Health portal or one BP monitor each week. |
| Reach | 8 weeks | Determined by the comparison of the sex frequency (percentage) of the enrolled participants compared to sex frequency of general population with chronic kidney disease, diabetes, and with hypertension in the United States (approximately 54% female and 46% male). |
| Implementation Issues | 8 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 collected with field notes from verbal conversations and textual data from email and text messages. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSarah Schrauben, MD, MSCE
University of Pennsylvania
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 66 years STANDARD_DEVIATION 11 |
| Body mass index | 30 kg/m^2 STANDARD_DEVIATION 10 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 26 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 18 Participants |
| Region of Enrollment United States | 36 participants |
| Sex: Female, Male Female | 21 Participants |
| Sex: Female, Male Male | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 36 | 0 / 37 |
| other Total, other adverse events | 0 / 36 | 0 / 37 |
| serious Total, serious adverse events | 0 / 36 | 0 / 37 |
Outcome results
None listed