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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 2
- 主要终点
- Feasibility: Adoption
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Feasibility: Adoption
时间窗: Collected throughout study (12 weeks)
Composite outcome determined by participant retention rate, any use of the SMART-HABITS dashboard; 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 dashboard/web app as measured by data usage statistics.
Feasibility: Adherence
时间窗: 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.
Feasibility: Change in Acceptability of mHealth From Baseline (Pre-study) and 12 Weeks (Post-study)
时间窗: 12 weeks
Determined through change in pre- and post-study scores on the three attitude statements toward mHealth, entitled Attitudes Toward Mobile Phone-Based Health Monitoring. Answers reported on 5-point Likert scale ranging from 1= strongly disagree, 2=disagree, 3=neither disagree or agree, 4=agree, to 5 = strongly agree (total range 3-15), with higher scores indicating better acceptability. If reporting a score on a scale, please include the unabbreviated scale title, the minimum and maximum values, and whether higher scores mean a better or worse outcome.
Feasibility: Acceptability of SMART-HABITS
时间窗: 4 weeks, 8 weeks, 12 weeks
Determined through satisfactory ratings on the System Usability Scale Survey (range is 0-100 with score above 68 considered adequate usability).
次要结局
- Change in Self-Management Scores From Baseline (Pre-study) and 12 Weeks (Post-study)(12 weeks)
- Reach: Qualitatively Similar Frequency (Percentage) of the Race Group Distribution of Randomized Participants vs. US General Population With Chronic Kidney Disease Stage 3 and 4 With Hypertension(At time of randomization)
- Change in CKD Knowledge Scores From Baseline (Pre-study) and 12 Weeks (Post-study)(12 weeks)
- Change in eHealth Literacy Scores From Baseline (Pre-study) and 12 Weeks (Post-study)(12 weeks)
- Reach: Qualitatively Similar Frequency of the Sex Distribution of Participants in the Study at the Time of Randomization vs. Published Information on the US General Population With Chronic Kidney Disease Stage 3 and 4 With Hypertension(At the time of randomization)
- Change in Kidney Disease Quality of Life From Baseline (Pre-study) and 12 Weeks (Post-study)(12 weeks)
- Effectiveness of Home Monitoring of BP(4, 8, and 12 weeks)
- Maintenance(12 weeks)
- Reach: Qualitatively Similar Frequency (Percentage) of the Ethnic Group Distribution of Randomized Participants vs. US General Population With Chronic Kidney Disease Stage 3 and 4 With Hypertension(Enrolled and randomized)
- Change in Self-Efficacy of Managing Chronic Disease Scores From Baseline (Pre-study) and 12 Weeks (Post-study)(12 weeks)
- Effectiveness of Step Monitoring(4, 8, and 12 weeks)
- Implementation Issues(12 weeks)