Home-base Kidney Care in Zuni Indians
关键词
抽象
描述
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.
日期
| 最后验证: | 11/30/2019 |
| 首次提交: | 09/07/2016 |
| 提交的预估入学人数: | 09/22/2016 |
| 首次发布: | 09/25/2016 |
| 上次提交的更新: | 12/02/2019 |
| 最近更新发布: | 12/03/2019 |
| 首次提交结果的日期: | 10/29/2018 |
| 首次提交质量检查结果的日期: | 12/02/2019 |
| 首次发布结果的日期: | 12/03/2019 |
| 实际学习开始日期: | 09/30/2013 |
| 预计主要完成日期: | 05/31/2016 |
| 预计完成日期: | 05/31/2016 |
状况或疾病
干预/治疗
Other: Education and Lifestyle Coaching
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| 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. |
资格标准
| 有资格学习的年龄 | 21 Years 至 21 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | 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. |
结果
主要结果指标
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]
次要成果指标
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]
