Home-base Kidney Care in Zuni Indians (HBKC)
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|ClinicalTrials.gov Identifier: NCT02915029|
Recruitment Status : Completed
First Posted : September 26, 2016
Last Update Posted : May 4, 2018
|Condition or disease||Intervention/treatment||Phase|
|Chronic Kidney Disease||Other: Educational and lifestyle coaching||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||125 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Reducing Health Disparity in Chronic Kidney Disease in Zuni Indians|
|Study Start Date :||October 2013|
|Actual Primary Completion Date :||June 2016|
|Actual Study Completion Date :||June 2016|
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: Educational 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.
- Patient Activation Measure (PAM) -13 item Questionnaire [ Time Frame: 12 months ]PAM questionnaire gives stages of patient activation. We will collect data about Changes in PAM stages from baseline to 12 months of intervention and compare it to Usual care group
- Diabetes lab measures [ Time Frame: 12 months ]Changes in clinical values
- kidney disease lab measures [ Time Frame: 12 months ]Changes in clinical values
- Blood pressure [ Time Frame: 12 months ]Changes in Clinical values
- Lipid Profile [ Time Frame: 12 months ]Changes in Clinical values
- Clinical Phenotype of Inflammation [ Time Frame: 12 months ]Changes in the value of marker of inflammation
- Body mass index [ Time Frame: 12 months ]Changes in the value of body mass index (BMI)
- Waist Circumference [ Time Frame: 12 months ]Changes in the value of Waist Circumference
- Psychosocial measures [ Time Frame: 12 months ]Changes in kidney disease specific quality of life (KDQOL) measures
- Nutritional measures [ Time Frame: 12 months ]Changes in 24hrs recall of diet questionnaire