Home-base Kidney Care in Zuni Indians
কীওয়ার্ডস
বিমূর্ত
বর্ণনা
Hypothesis: (1) The Zuni Health Initiative (ZHI) can integrate an innovative approach to Home based kidney care (HBKC) utilizing tribal Community Health Representatives (CHRs), Point of Care (POC) technology, telemedicine and motivational messaging in conjunction with patient preferences and Patient Activation Measures (PAM) into the chronic care model to improve the detection and treatment of Chronic Kidney Disease (CKD) and related risk factors; (2) This model is generalizable to other high-risk communities e.g., Hispanic and American Indians in Guadalupe, AZ being studied by NIDDK, NIH-Phoenix.
Specific Aim 1: Re-phenotype prior participants, to identify incident cases of CKD, estimate progression rates, and identify participants for the proposed study of HBKC;
Specific Aim 2: Conduct a pilot study of HBKC in 120 people. Randomize households in a 1:1 allocation to usual care versus HBKC. Compare the changes in Patient Activation measure (PAM), Adherence, BP, weight, HbA1c, UACR, eGFR and lipid profiles between the two groups over the 1-year intervention period;
Specific Aim 3: Inform the design of the full-scale study by estimating anticipated recruitment, adherence and dropout rates, sample size and reassessing the approach;
Specific Aim 4: Assess the exportability of the HBKC model to Hispanics and American Indians in Guadalupe, AZ.
Study Outcomes: (1) The PAM and adherence; (2) Changes in clinical phenotypes including Cr, UACR, A1c, body weight, BMI, fasting glucose, blood pressure (BP), plasma lipids, and inflammatory markers; (3) Changes in the quantitative traits such as diet and scores from a battery of mental-health, self-efficacy, and quality of life instruments.
Health Impact: The active participation of the Zuni tribal leadership and IHS in this protocol, and the general affordability of Zuni native CHR personnel, render the outcomes that will be demonstrated by this proposal easily sustainable over the long term. If successful, this program has the potential to change best-practices for CKD progression and to reduce health disparities in a cost-effective and sustainable manner.
তারিখ
| সর্বশেষ যাচাই করা হয়েছে: | 11/30/2019 |
| প্রথম জমা দেওয়া: | 09/07/2016 |
| আনুমানিক তালিকাভুক্তি জমা দেওয়া হয়েছে: | 09/22/2016 |
| প্রথম পোস্ট: | 09/25/2016 |
| সর্বশেষ আপডেট জমা দেওয়া হয়েছে: | 12/02/2019 |
| সর্বশেষ আপডেট পোস্ট: | 12/03/2019 |
| প্রথম জমা দেওয়া ফলাফলের তারিখ: | 10/29/2018 |
| প্রথম জমা দেওয়া কিউসির ফলাফলের তারিখ: | 12/02/2019 |
| প্রথম পোস্ট ফলাফলের তারিখ: | 12/03/2019 |
| আসল অধ্যয়ন শুরুর তারিখ: | 09/30/2013 |
| আনুমানিক প্রাথমিক সমাপ্তির তারিখ: | 05/31/2016 |
| আনুমানিক অধ্যয়ন সমাপ্তির তারিখ: | 05/31/2016 |
অবস্থা বা রোগ
হস্তক্ষেপ / চিকিত্সা
Other: Education and Lifestyle Coaching
পর্যায়
বাহু গ্রুপ
| বাহু | হস্তক্ষেপ / চিকিত্সা |
|---|---|
| Experimental: Education and Lifestyle Coaching Education and life style coaching includes:
education about diabetes and kidney disease Coaching /counseling about lifestyle, nutrition and medication adherence | Other: Education and Lifestyle Coaching Educational lifestyle and patient activation is a CHR lead home visits every other week to provide education on healthy lifestyles (diet, exercise, alcohol abuse and smoking) as patient preference; Education provided on management of diabetes, hypertension and hyperlipidemia POC testing for A1C and microalbuminuria conducted at patient homes. Lifestyle and diet related Motivational messaging carried out regularly. Patient will receive group session at the clinic every quarters.
Control arm will receive their usual care provided by IHS. The control group will receive a health evaluation at the initiation of the study and at the 6-month and 12-month. |
| No Intervention: Usual care (UC) control arm once randomize to the Usual Care control group, the participants are left alone and are suggested to contact their providers for health care. The group gets labs and other survey done at 6 and 12 months of the intervention. |
যোগ্যতার মানদণ্ড
| বয়স অধ্যয়নের জন্য যোগ্য | 21 Years প্রতি 21 Years |
| লিঙ্গ অধ্যয়নের জন্য যোগ্য | All |
| স্বাস্থ্যকর স্বেচ্ছাসেবীদের গ্রহণ করে | হ্যাঁ |
| নির্ণায়ক | Inclusion Criteria: - Clinical diagnosis of diabetes - Clinical diagnosis of microalbuminuria - Must be living in a household with more than 1 living participant - Age 21 to 80 years - Must have negative pregnancy test in women of child-bearing potential Exclusion Criteria: - Life expectancy < 1 year - On dialysis - With renal transplant - Pregnancy or absence of reliable birth control in women of child-bearing potential - Malignancy except non-melanoma skin cancer - Blind - Unwilling or unable to give informed consent. |
ফলাফল
প্রাথমিক ফলাফল ব্যবস্থা
1. Patient Activation Measure (PAM) -13 Item Questionnaire [12 months follow-up minus baseline values]
2. Patient Activation Measure (PAM) Level Greater Than 2 [12 months follow-up]
মাধ্যমিক ফলাফলের ব্যবস্থা
1. A1c [12 months minus baseline values]
2. Diastolic Blood Pressure [12 months minus baseline values]
3. Systolic Blood Pressure [12 months minus baseline values]
4. Body Mass Index [12 months minus baseline values]
5. Low-density Lipoprotein LDL Cholesterol [12 months minus baseline values]
6. High-density Lipoprotein HDL Cholesterol [12 months minus baseline values]
7. Triglycerides [12 months minus baseline values]
8. Serum Total Cholesterol [12 months minus baseline values]
9. High Sensitive C-reactive Protein-hsCRP [12 months minus baseline values]
10. Serum Total Protein [12 months minus baseline values]
11. eGFR [12 months minus baseline values]
12. UACR [12 months minus baseline values]
13. KDQOL-Symptom/Problem [12 months minus baseline values]
14. KDQOL-EKD [12 months minus baseline values]
15. KDQOL-BKD [12 months minus baseline values]
16. KDQOL-SF12 Physical Score [12 months minus baseline values]
17. KDQOL-SF12 Mental Score [12 months minus baseline values]
18. 8-Item Morisky Score [12 months minus baseline values]
