N/A
N=47
Supporting Self-Management of Healthy Behaviors in Chronic Kidney Disease
Renal Insufficiency, Chronic · Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT04858295 ↗Enrolled (actual)
47
Serious AEs
0.0%
Results posted
Apr 2024
Primary outcome: Primary: Feasibility: Adoption — 44; 42; 18; 22 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Texting (Device); mHealth app (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Pennsylvania
- Primary completion
- Jun 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility: Adoption |
44; 42; 18; 22 | — |
| PRIMARY Feasibility: Adherence |
36; 30; 43; 43 | — |
| PRIMARY Feasibility: Change in Acceptability of mHealth From Baseline (Pre-study) and 12 Weeks (Post-study) |
12 | — |
| PRIMARY Feasibility: Acceptability of SMART-HABITS |
77; 64.5; 70.1; 65.9; 71.6; 65.6 | — |
| SECONDARY Change in CKD Knowledge Scores From Baseline (Pre-study) and 12 Weeks (Post-study) |
66.7 | — |
| SECONDARY Change in Self-Efficacy of Managing Chronic Disease Scores From Baseline (Pre-study) and 12 Weeks (Post-study) |
7.8 | — |
| SECONDARY Change in Self-Management Scores From Baseline (Pre-study) and 12 Weeks (Post-study) |
72 | — |
| SECONDARY Change in eHealth Literacy Scores From Baseline (Pre-study) and 12 Weeks (Post-study) |
30.5 | — |
| SECONDARY Change in Kidney Disease Quality of Life From Baseline (Pre-study) and 12 Weeks (Post-study) |
77.5; 83.4; 85.9 | — |
| SECONDARY Effectiveness of Home Monitoring of BP |
125; 130; 125; 129; 126; 129 | — |
| SECONDARY Effectiveness of Step Monitoring |
6846; 5897; 6758; 6250; 7387; 6106 | — |
| SECONDARY Maintenance |
43 | — |
| SECONDARY Implementation Issues |
— | — |
| SECONDARY 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 |
23; 24 | — |
| SECONDARY 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 |
21; 23; 1; 2 | — |
| SECONDARY 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 |
1; 46 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT04858295). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.