Chronic Kidney Disease, Hypertension
Conditions
Keywords
Hospitalized Patients, African American, Motivational Interviewing
Brief summary
Intensive Patient Referral and Education Program prior to Renal Replacement Therapy (iPREP-RRT) is a 12-week intervention that identifies hospitalized African Americans with advanced chronic kidney disease (CKD) and provides them with hospital- and community-based education, navigation and self-management support. Participants will be randomized to the iPREP-RRT intervention versus enhanced usual care.
Detailed description
The Intensive Patient Referral and Education Program prior to Renal Replacement Therapy (iPREP-RRT) will determine the efficacy of the hospital-based patient intervention (HPI) in improving patient knowledge, self-efficacy, and intent for chronic kidney disease (CKD) self-management and renal replacement therapy (RRT) planning; and 2) determine the efficacy of the community-based patient intervention (CPI) during a 12 week outpatient follow-up program that combines outpatient follow-up with multiple modes of communication (in-person session, phone calls and personalized text messaging) and navigation in increasing participants' initiation and maintenance of CKD self-management and RRT planning, compared to enhanced usual care (attention controls). The goal is to improve knowledge and outcomes for African American patients with advanced CKD through the iPREP-RRT. To accomplish this goal, investigators will 1) determine the efficacy of the hospital-based patient intervention (HPI) in improving participant knowledge, self-efficacy, and intent for CKD self-management and RRT planning; and 2) determine the efficacy of the community-based patient intervention (CPI) during a 12 week outpatient program that combines outpatient follow-up with multiple modes of communication (in-person session, phone calls and personalized text messaging) and navigation in increasing initiation and maintenance of CKD self-management and RRT planning, compared to enhanced usual care. To that end, investigators will conduct a one-site randomized controlled trial, where participants will be randomized in a 1:1 ratio into either the intervention (iPREP-RRT) or control groups (enhanced usual care). The randomization will be stratified by baseline blood pressure (controlled or uncontrolled). Participants will receive 2 in-person education sessions (during hospitalization and week 12), phone sessions at weeks 4 and 8, and weekly personalized text message contact. The duration of the intervention will be 12 weeks, and participants and controls will be assessed pre-intervention, immediately post-hospital based intervention, at 4 ,8 and 12 weeks during community-based intervention and 4 weeks post-intervention (16 weeks).
Interventions
BEHAVIORALIn-Person Patient Education
In-person patient education about CKD, CKD risk factor management and renal replacement therapy options.
BEHAVIORALCommitment to Change
Motivational interviewing to assist participants in committing to change in CKD management or RRT selection.
BEHAVIORALBlood pressure monitoring
Participants will learn how to check their blood pressure and will receive a blood pressure cuff for home.
BEHAVIORALWritten Patient Education
Written patient education booklet about general health care management including taking medications, having a primary care doctor, weight management and exercise.
BEHAVIORALText-based reinforcement for CKD self-management
Patient educator will use text messages based on social cognitive theory to remind participants about and reinforce goals set around CKD self-management, blood pressure control and RRT selection
BEHAVIORALCommunity-based education session, reinforcement for self-management
Patient educator will use provide a booster session based on social cognitive theory to remind participants about and reinforce goals set around CKD self-management, blood pressure control and RRT selection
BEHAVIORALText-based reinforcement for general health self-management
Patient educator will use text messages to send general health management messages
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Masking description
The care provider will not be involved in the enrollment or assessment process. The outcomes assessor will analyze the outcomes without knowledge of allocation.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Patients over the age of 18 and under 70 * Admitted to the University of Chicago inpatient general medicine service * Likely hospital stay greater than 48 hours * Diagnosis of advanced CKD (Stage 3B or above, as determine by problem list, ICD- 10 codes or eGFR\<45 during admission and from previous medical encounters) * Self-identify as Black or African American
Exclusion criteria
* Non-English speaking * Unable to communicate due to current medical status * Unable to consent due to mental status * Expected hospital stay less than 24 hour * Current admission in ICU
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Kidney Disease Knowledge Questionnaire (KIKS) | Baseline, 1 day Post Brief Intervention, Week 4, Week 12, Week 16 | The Kidney Disease Knowledge Questionnaire (KIKS) is a validated instrument that assesses CKD knowledge. Scores range from 0 (no knowledge)-28 (full knowledge). Change =Post intervention-Baseline scores, and Follow-up (Week 4, Week 12, Week 16)-Baseline |
| ESRD Knowledge | Baseline, 1 day Post Brief Intervention, Week 4, Week 12, Week 16 | The Kidney Failure Treatment Knowledge is an investigator developed tool that assesses knowledge of 6 ESKD treatment options using a Likert scale (0=no knowledge and 4=a great deal of knowledge). Possible scores range from 0-24. Change =Post intervention-Baseline scores, and Follow-up (Week 4, Week 12, Week 16)-Baseline |
| Blood Pressure Knowledge | Baseline, 1 day Post Brief Intervention, Week 4, Week 12, Week 16 | Blood Pressure Knowledge Scale (BPKS, revised) is an 11-item scale; a summed score is computed. Scores range from 7 to 77 and higher scores indicate greater knowledge. Change =Post intervention-Baseline scores, and Follow-up (Week 4, Week 12, Week 16)-Baseline |
| CKD Self-Management | Baseline, Week 8, Week 12, Week 16 | The CKD Self-Management Knowledge Toolkit (CKD-SMKT) is a validated 10 item survey to assess participants CKD self-management behaviors. The survey consists of 2 true /false questions for each of the 10 self-care domains and can be scored from 0 (no self-care) to 20 (full self-care). Change is Follow-up Score (Week 8, Week 12, Week 16)-Baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CKD Self-Efficacy | Baseline, 1 day Post Brief Intervention, Week 4, Week 8, Week 12, Week 16 | CKD Self-Efficacy Scale (CKD-SE), 25-item CKD-SE instrument can be used for the early identification of patients with low self-efficacy. The scale is from 0 to 10 points, and a larger number indicates a higher level of confidence regarding the management activity. The total score on the scale ranges between 25 and 250. The total score can be classified into three categories: low self-efficacy (score less than 30), moderate (scores between 30 to 70), and high self-efficacy (score more than 70). Change is Follow-up Score (Week 8, Week 12, Week 16)-Baseline |
| CKD Health Intent | Baseline, 1 day Post-Brief Intervention, Week 4 | The Health Intent Survey is an investigator-developed tool to measure participants stated intent to make healthy lifestyle changes. There are 12 questions each scored on a 5 point scale from 1=extremely unlikely to 5=extremely likely (60 total possible points with higher scores better). Change=Follow-up (1 day post-intervention, Wk4, wk 8, wk 12, wk16) - baseline. |
Countries
United States
Outcome results
None listed