Trial Outcomes & Findings for Home-Based Kidney Care in Native American's of New Mexico (HBKC) (NCT NCT03179085)
NCT ID: NCT03179085
Last Updated: 2025-04-08
Results Overview
Assesses an individual's knowledge, skill, and confidence for managing one's health and healthcare. PAM total scores have a theoretical range from 0 to 100, with higher scores representing greater patient activation.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
529 participants
Primary outcome timeframe
Baseline, 6 and 12 months
Results posted on
2025-04-08
Participant Flow
A total of 529 individuals were consented for participation in the study. These participants responded to screening questionnaires which included POC testing, Blood pressure, medical history and physical assessments. From those 529 participants, a total of 286 did not meet inclusion criteria for randomization and 57 declined further participation in the study. Therefore, we randomized 186 participants, 93 to the HBKC care intervention and 93 to the Delay Intervention.
The study enrolled males and females who displayed evidence of diabetic chronic kidney disease and who: were age 21 to 80 years; had a negative pregnancy test in women of child-bearing potential; were diagnosed diabetics or HbA1c \>7; had BMI \>27 kg/m2, and had UACR \>=30 mg/g. Exclusion criteria: life expectancy \< 1 year; absence of reliable birth control in women of child-bearing potential; malignancy except non-melanoma skin cancer; blind; and unwilling or unable to give informed consent.
Participant milestones
| Measure |
Usual Care / Delayed Intervention
Participants randomized to the control group will receive usual care by their provider for 12 months. They will also attend one group class taught by CHRs in which they will learn basic information about diabetes prevention. DI participants will receive publicly-available literature that reinforces the information given in class, and they will have no other contact with study staff aside from during study data collection visits at baseline and 12 months. After 12 months of usual care, patients will enter into the delayed intervention where they will complete 12 months of Home-Based Kidney Care (HBKC).
Home-Based Kidney Care: All subjects randomized to the HBKC arm will be visited by a community health representative in their home at least every two weeks for the duration of the 12 month intervention. Each visit will last 30 minutes to one hour and cover materials like, (1) Kidney 101, (2) weight management, (3) exercise, (4) healthy eating, (5) medication management, (6) coping with stress, (7) risk factor management (i.e.- blood pressure, hyperlipidemia), (8) alcohol and substance abuse, (9) smoking cessation, and related health concerns.
|
Home-Based Kidney Care Intervention
All subjects randomized to the HBKC arm will be visited by a CHR in their home at least every two weeks for the duration of the 12 month intervention. Each visit will last 30 minutes to one hour and participant preference will be incorporated into the HBKC intervention arm by allowing participants to prioritize the order in which curriculum topic areas will be emphasized by the CHRs. Topics from currently available NIDDK and IHS kidney education materials will include: (1) Kidney 101, (2) weight management, (3) exercise, (4) healthy eating, (5) medication management, (6) coping with stress, (7) risk factor management (i.e.- blood pressure, hyperlipidemia), (8) alcohol and substance abuse, (9) smoking cessation, and related health concerns.
Home-Based Kidney Care: All subjects randomized to the HBKC arm will be visited by a community health representative in their home at least every two weeks for the duration of the 12 month intervention. Each visit will last 30 minutes to one hour and cover materials like, (1) Kidney 101, (2) weight management, (3) exercise, (4) healthy eating, (5) medication management, (6) coping with stress, (7) risk factor management (i.e.- blood pressure, hyperlipidemia), (8) alcohol and substance abuse, (9) smoking cessation, and related health concerns.
|
|---|---|---|
|
Overall Study
STARTED
|
93
|
93
|
|
Overall Study
COMPLETED
|
93
|
93
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Missing age data for some participants.
Baseline characteristics by cohort
| Measure |
Usual Care / Delayed Intervention
n=93 Participants
Participants randomized to the control group will receive usual care by their provider for 12 months. They will also attend one group class taught by CHRs in which they will learn basic information about diabetes prevention. DI participants will receive publicly-available literature that reinforces the information given in class, and they will have no other contact with study staff aside from during study data collection visits at baseline and 12 months. After 12 months of usual care, patients will enter into the delayed intervention where they will complete 12 months of Home-Based Kidney Care (HBKC).
Home-Based Kidney Care: All subjects randomized to the HBKC arm will be visited by a community health representative in their home at least every two weeks for the duration of the 12 month intervention. Each visit will last 30 minutes to one hour and cover materials like, (1) Kidney 101, (2) weight management, (3) exercise, (4) healthy eating, (5) medication management, (6) coping with stress, (7) risk factor management (i.e.- blood pressure, hyperlipidemia), (8) alcohol and substance abuse, (9) smoking cessation, and related health concerns.
|
Home-Based Kidney Care Intervention
n=93 Participants
All subjects randomized to the HBKC arm will be visited by a CHR in their home at least every two weeks for the duration of the 12 month intervention. Each visit will last 30 minutes to one hour and participant preference will be incorporated into the HBKC intervention arm by allowing participants to prioritize the order in which curriculum topic areas will be emphasized by the CHRs. Topics from currently available NIDDK and IHS kidney education materials will include: (1) Kidney 101, (2) weight management, (3) exercise, (4) healthy eating, (5) medication management, (6) coping with stress, (7) risk factor management (i.e.- blood pressure, hyperlipidemia), (8) alcohol and substance abuse, (9) smoking cessation, and related health concerns.
Home-Based Kidney Care: All subjects randomized to the HBKC arm will be visited by a community health representative in their home at least every two weeks for the duration of the 12 month intervention. Each visit will last 30 minutes to one hour and cover materials like, (1) Kidney 101, (2) weight management, (3) exercise, (4) healthy eating, (5) medication management, (6) coping with stress, (7) risk factor management (i.e.- blood pressure, hyperlipidemia), (8) alcohol and substance abuse, (9) smoking cessation, and related health concerns.
|
Total
n=186 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.2 years
STANDARD_DEVIATION 14.8 • n=91 Participants • Missing age data for some participants.
|
56.1 years
STANDARD_DEVIATION 14.6 • n=92 Participants • Missing age data for some participants.
|
56.7 years
STANDARD_DEVIATION 14.6 • n=183 Participants • Missing age data for some participants.
|
|
Sex: Female, Male
Female
|
52 Participants
n=92 Participants • Missing gender data for some participants.
|
52 Participants
n=92 Participants • Missing gender data for some participants.
|
104 Participants
n=184 Participants • Missing gender data for some participants.
|
|
Sex: Female, Male
Male
|
40 Participants
n=92 Participants • Missing gender data for some participants.
|
40 Participants
n=92 Participants • Missing gender data for some participants.
|
80 Participants
n=184 Participants • Missing gender data for some participants.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
93 Participants
n=93 Participants
|
93 Participants
n=93 Participants
|
186 Participants
n=186 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=93 Participants
|
0 Participants
n=186 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=93 Participants
|
0 Participants
n=186 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=93 Participants
|
0 Participants
n=186 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=93 Participants
|
0 Participants
n=93 Participants
|
0 Participants
n=186 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=93 Participants
|
0 Participants
n=186 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=93 Participants
|
0 Participants
n=186 Participants
|
PRIMARY outcome
Timeframe: Baseline, 6 and 12 monthsPopulation: Missing PAM scores data and the number differ for each time point. Participants were invited to participate at each time point regardless of participation in other study periods. We note that this study took place during COVID 19 pandemic.
Assesses an individual's knowledge, skill, and confidence for managing one's health and healthcare. PAM total scores have a theoretical range from 0 to 100, with higher scores representing greater patient activation.
Outcome measures
| Measure |
Usual Care / Delayed Intervention
n=92 Participants
Participants randomized to the control group will receive usual care by their provider for 12 months. They will also attend one group class taught by CHRs in which they will learn basic information about diabetes prevention. DI participants will receive publicly-available literature that reinforces the information given in class, and they will have no other contact with study staff aside from during study data collection visits at baseline and 12 months. After 12 months of usual care, patients will enter into the delayed intervention where they will complete 12 months of Home-Based Kidney Care (HBKC).
Home-Based Kidney Care: All subjects randomized to the HBKC arm will be visited by a community health representative in their home at least every two weeks for the duration of the 12 month intervention. Each visit will last 30 minutes to one hour and cover materials like, (1) Kidney 101, (2) weight management, (3) exercise, (4) healthy eating, (5) medication management, (6) coping with stress, (7) risk factor management (i.e.- blood pressure, hyperlipidemia), (8) alcohol and substance abuse, (9) smoking cessation, and related health concerns.
|
Home-Based Kidney Care Intervention
n=92 Participants
All subjects randomized to the HBKC arm will be visited by a CHR in their home at least every two weeks for the duration of the 12 month intervention. Each visit will last 30 minutes to one hour and participant preference will be incorporated into the HBKC intervention arm by allowing participants to prioritize the order in which curriculum topic areas will be emphasized by the CHRs. Topics from currently available NIDDK and IHS kidney education materials will include: (1) Kidney 101, (2) weight management, (3) exercise, (4) healthy eating, (5) medication management, (6) coping with stress, (7) risk factor management (i.e.- blood pressure, hyperlipidemia), (8) alcohol and substance abuse, (9) smoking cessation, and related health concerns.
Home-Based Kidney Care: All subjects randomized to the HBKC arm will be visited by a community health representative in their home at least every two weeks for the duration of the 12 month intervention. Each visit will last 30 minutes to one hour and cover materials like, (1) Kidney 101, (2) weight management, (3) exercise, (4) healthy eating, (5) medication management, (6) coping with stress, (7) risk factor management (i.e.- blood pressure, hyperlipidemia), (8) alcohol and substance abuse, (9) smoking cessation, and related health concerns.
|
|---|---|---|
|
The Patient Activation Measure (PAM)
Baseline PAM scores
|
60.8 score on a scale
Standard Error 2.12
|
61.5 score on a scale
Standard Error 2.06
|
|
The Patient Activation Measure (PAM)
6-month change in PAM scores
|
1.73 score on a scale
Standard Error 1.64
|
3.44 score on a scale
Standard Error 1.55
|
|
The Patient Activation Measure (PAM)
12-month change in PAM scores
|
2.28 score on a scale
Standard Error 2.05
|
3.59 score on a scale
Standard Error 1.94
|
SECONDARY outcome
Timeframe: Baseline. Change from baseline at 6 and 12 monthsPopulation: Not all enrolled participants provided a baseline blood sample which resulted in fewer analyzed than enrolled.
Hemoglobin A1C measured as percent of glycosylated high hemoglobin cells
Outcome measures
| Measure |
Usual Care / Delayed Intervention
n=65 Participants
Participants randomized to the control group will receive usual care by their provider for 12 months. They will also attend one group class taught by CHRs in which they will learn basic information about diabetes prevention. DI participants will receive publicly-available literature that reinforces the information given in class, and they will have no other contact with study staff aside from during study data collection visits at baseline and 12 months. After 12 months of usual care, patients will enter into the delayed intervention where they will complete 12 months of Home-Based Kidney Care (HBKC).
Home-Based Kidney Care: All subjects randomized to the HBKC arm will be visited by a community health representative in their home at least every two weeks for the duration of the 12 month intervention. Each visit will last 30 minutes to one hour and cover materials like, (1) Kidney 101, (2) weight management, (3) exercise, (4) healthy eating, (5) medication management, (6) coping with stress, (7) risk factor management (i.e.- blood pressure, hyperlipidemia), (8) alcohol and substance abuse, (9) smoking cessation, and related health concerns.
|
Home-Based Kidney Care Intervention
n=72 Participants
All subjects randomized to the HBKC arm will be visited by a CHR in their home at least every two weeks for the duration of the 12 month intervention. Each visit will last 30 minutes to one hour and participant preference will be incorporated into the HBKC intervention arm by allowing participants to prioritize the order in which curriculum topic areas will be emphasized by the CHRs. Topics from currently available NIDDK and IHS kidney education materials will include: (1) Kidney 101, (2) weight management, (3) exercise, (4) healthy eating, (5) medication management, (6) coping with stress, (7) risk factor management (i.e.- blood pressure, hyperlipidemia), (8) alcohol and substance abuse, (9) smoking cessation, and related health concerns.
Home-Based Kidney Care: All subjects randomized to the HBKC arm will be visited by a community health representative in their home at least every two weeks for the duration of the 12 month intervention. Each visit will last 30 minutes to one hour and cover materials like, (1) Kidney 101, (2) weight management, (3) exercise, (4) healthy eating, (5) medication management, (6) coping with stress, (7) risk factor management (i.e.- blood pressure, hyperlipidemia), (8) alcohol and substance abuse, (9) smoking cessation, and related health concerns.
|
|---|---|---|
|
HbA1c
Baseline
|
8.65 percent of cells
Standard Deviation 2.13
|
8.54 percent of cells
Standard Deviation 2.25
|
|
HbA1c
Change from baseline to 6 months
|
-0.31 percent of cells
Standard Deviation 2.80
|
-0.34 percent of cells
Standard Deviation 1.97
|
|
HbA1c
Change from baseline to 12 months
|
-0.23 percent of cells
Standard Deviation 1.74
|
-0.18 percent of cells
Standard Deviation 2.14
|
SECONDARY outcome
Timeframe: Baseline. Change from baseline at 6 and 12 monthsPopulation: Analysis were restricted to those who provided valid blood samples.
amount of glucose in the blood measured as mg/dL - milligrams per deciliter
Outcome measures
| Measure |
Usual Care / Delayed Intervention
n=65 Participants
Participants randomized to the control group will receive usual care by their provider for 12 months. They will also attend one group class taught by CHRs in which they will learn basic information about diabetes prevention. DI participants will receive publicly-available literature that reinforces the information given in class, and they will have no other contact with study staff aside from during study data collection visits at baseline and 12 months. After 12 months of usual care, patients will enter into the delayed intervention where they will complete 12 months of Home-Based Kidney Care (HBKC).
Home-Based Kidney Care: All subjects randomized to the HBKC arm will be visited by a community health representative in their home at least every two weeks for the duration of the 12 month intervention. Each visit will last 30 minutes to one hour and cover materials like, (1) Kidney 101, (2) weight management, (3) exercise, (4) healthy eating, (5) medication management, (6) coping with stress, (7) risk factor management (i.e.- blood pressure, hyperlipidemia), (8) alcohol and substance abuse, (9) smoking cessation, and related health concerns.
|
Home-Based Kidney Care Intervention
n=73 Participants
All subjects randomized to the HBKC arm will be visited by a CHR in their home at least every two weeks for the duration of the 12 month intervention. Each visit will last 30 minutes to one hour and participant preference will be incorporated into the HBKC intervention arm by allowing participants to prioritize the order in which curriculum topic areas will be emphasized by the CHRs. Topics from currently available NIDDK and IHS kidney education materials will include: (1) Kidney 101, (2) weight management, (3) exercise, (4) healthy eating, (5) medication management, (6) coping with stress, (7) risk factor management (i.e.- blood pressure, hyperlipidemia), (8) alcohol and substance abuse, (9) smoking cessation, and related health concerns.
Home-Based Kidney Care: All subjects randomized to the HBKC arm will be visited by a community health representative in their home at least every two weeks for the duration of the 12 month intervention. Each visit will last 30 minutes to one hour and cover materials like, (1) Kidney 101, (2) weight management, (3) exercise, (4) healthy eating, (5) medication management, (6) coping with stress, (7) risk factor management (i.e.- blood pressure, hyperlipidemia), (8) alcohol and substance abuse, (9) smoking cessation, and related health concerns.
|
|---|---|---|
|
Blood Glucose Levels
Baseline
|
172.06 milligrams per deciliter
Standard Deviation 87.12
|
183.18 milligrams per deciliter
Standard Deviation 111.64
|
|
Blood Glucose Levels
Change from baseline to 6months
|
24.06 milligrams per deciliter
Standard Deviation 103.02
|
-10.59 milligrams per deciliter
Standard Deviation 100.03
|
|
Blood Glucose Levels
Change from baseline to 12 months
|
28.62 milligrams per deciliter
Standard Deviation 79.19
|
3.26 milligrams per deciliter
Standard Deviation 110.88
|
SECONDARY outcome
Timeframe: Baseline. Change from baseline at 6 and 12 monthsPopulation: Analysis were restricted to those who provided valid blood samples.
High density lipoprotein as mg/dL - milligrams per deciliter
Outcome measures
| Measure |
Usual Care / Delayed Intervention
n=65 Participants
Participants randomized to the control group will receive usual care by their provider for 12 months. They will also attend one group class taught by CHRs in which they will learn basic information about diabetes prevention. DI participants will receive publicly-available literature that reinforces the information given in class, and they will have no other contact with study staff aside from during study data collection visits at baseline and 12 months. After 12 months of usual care, patients will enter into the delayed intervention where they will complete 12 months of Home-Based Kidney Care (HBKC).
Home-Based Kidney Care: All subjects randomized to the HBKC arm will be visited by a community health representative in their home at least every two weeks for the duration of the 12 month intervention. Each visit will last 30 minutes to one hour and cover materials like, (1) Kidney 101, (2) weight management, (3) exercise, (4) healthy eating, (5) medication management, (6) coping with stress, (7) risk factor management (i.e.- blood pressure, hyperlipidemia), (8) alcohol and substance abuse, (9) smoking cessation, and related health concerns.
|
Home-Based Kidney Care Intervention
n=71 Participants
All subjects randomized to the HBKC arm will be visited by a CHR in their home at least every two weeks for the duration of the 12 month intervention. Each visit will last 30 minutes to one hour and participant preference will be incorporated into the HBKC intervention arm by allowing participants to prioritize the order in which curriculum topic areas will be emphasized by the CHRs. Topics from currently available NIDDK and IHS kidney education materials will include: (1) Kidney 101, (2) weight management, (3) exercise, (4) healthy eating, (5) medication management, (6) coping with stress, (7) risk factor management (i.e.- blood pressure, hyperlipidemia), (8) alcohol and substance abuse, (9) smoking cessation, and related health concerns.
Home-Based Kidney Care: All subjects randomized to the HBKC arm will be visited by a community health representative in their home at least every two weeks for the duration of the 12 month intervention. Each visit will last 30 minutes to one hour and cover materials like, (1) Kidney 101, (2) weight management, (3) exercise, (4) healthy eating, (5) medication management, (6) coping with stress, (7) risk factor management (i.e.- blood pressure, hyperlipidemia), (8) alcohol and substance abuse, (9) smoking cessation, and related health concerns.
|
|---|---|---|
|
HDL
Baseline
|
46.08 milligrams per deciliter
Standard Deviation 12.58
|
46.38 milligrams per deciliter
Standard Deviation 12.03
|
|
HDL
Change from baseline to 6 months
|
0.21 milligrams per deciliter
Standard Deviation 6.93
|
-0.61 milligrams per deciliter
Standard Deviation 7.25
|
|
HDL
Change from baseline to 12 months
|
-1.83 milligrams per deciliter
Standard Deviation 7.95
|
-1.59 milligrams per deciliter
Standard Deviation 8.94
|
SECONDARY outcome
Timeframe: Baseline. Change from baseline at 6 and 12 monthsPopulation: Analysis were restricted to those who provided valid blood samples.
Low density lipoprotein as mg/dL - milligrams per deciliter
Outcome measures
| Measure |
Usual Care / Delayed Intervention
n=64 Participants
Participants randomized to the control group will receive usual care by their provider for 12 months. They will also attend one group class taught by CHRs in which they will learn basic information about diabetes prevention. DI participants will receive publicly-available literature that reinforces the information given in class, and they will have no other contact with study staff aside from during study data collection visits at baseline and 12 months. After 12 months of usual care, patients will enter into the delayed intervention where they will complete 12 months of Home-Based Kidney Care (HBKC).
Home-Based Kidney Care: All subjects randomized to the HBKC arm will be visited by a community health representative in their home at least every two weeks for the duration of the 12 month intervention. Each visit will last 30 minutes to one hour and cover materials like, (1) Kidney 101, (2) weight management, (3) exercise, (4) healthy eating, (5) medication management, (6) coping with stress, (7) risk factor management (i.e.- blood pressure, hyperlipidemia), (8) alcohol and substance abuse, (9) smoking cessation, and related health concerns.
|
Home-Based Kidney Care Intervention
n=69 Participants
All subjects randomized to the HBKC arm will be visited by a CHR in their home at least every two weeks for the duration of the 12 month intervention. Each visit will last 30 minutes to one hour and participant preference will be incorporated into the HBKC intervention arm by allowing participants to prioritize the order in which curriculum topic areas will be emphasized by the CHRs. Topics from currently available NIDDK and IHS kidney education materials will include: (1) Kidney 101, (2) weight management, (3) exercise, (4) healthy eating, (5) medication management, (6) coping with stress, (7) risk factor management (i.e.- blood pressure, hyperlipidemia), (8) alcohol and substance abuse, (9) smoking cessation, and related health concerns.
Home-Based Kidney Care: All subjects randomized to the HBKC arm will be visited by a community health representative in their home at least every two weeks for the duration of the 12 month intervention. Each visit will last 30 minutes to one hour and cover materials like, (1) Kidney 101, (2) weight management, (3) exercise, (4) healthy eating, (5) medication management, (6) coping with stress, (7) risk factor management (i.e.- blood pressure, hyperlipidemia), (8) alcohol and substance abuse, (9) smoking cessation, and related health concerns.
|
|---|---|---|
|
LDL
Baseline
|
73.66 milligrams per deciliter
Standard Deviation 31.59
|
77.54 milligrams per deciliter
Standard Deviation 48.11
|
|
LDL
Change from baseline to 6 months
|
12.59 milligrams per deciliter
Standard Deviation 72.37
|
-8.33 milligrams per deciliter
Standard Deviation 48.49
|
|
LDL
Change from baseline to 12 months
|
4.18 milligrams per deciliter
Standard Deviation 23.08
|
11.81 milligrams per deciliter
Standard Deviation 25.00
|
SECONDARY outcome
Timeframe: Baseline. Change from baseline at 6 and 12 monthsPopulation: Analysis were restricted to those who provided valid blood samples.
Serum creatinine measured as mg/dL - milligrams per deciliter
Outcome measures
| Measure |
Usual Care / Delayed Intervention
n=65 Participants
Participants randomized to the control group will receive usual care by their provider for 12 months. They will also attend one group class taught by CHRs in which they will learn basic information about diabetes prevention. DI participants will receive publicly-available literature that reinforces the information given in class, and they will have no other contact with study staff aside from during study data collection visits at baseline and 12 months. After 12 months of usual care, patients will enter into the delayed intervention where they will complete 12 months of Home-Based Kidney Care (HBKC).
Home-Based Kidney Care: All subjects randomized to the HBKC arm will be visited by a community health representative in their home at least every two weeks for the duration of the 12 month intervention. Each visit will last 30 minutes to one hour and cover materials like, (1) Kidney 101, (2) weight management, (3) exercise, (4) healthy eating, (5) medication management, (6) coping with stress, (7) risk factor management (i.e.- blood pressure, hyperlipidemia), (8) alcohol and substance abuse, (9) smoking cessation, and related health concerns.
|
Home-Based Kidney Care Intervention
n=73 Participants
All subjects randomized to the HBKC arm will be visited by a CHR in their home at least every two weeks for the duration of the 12 month intervention. Each visit will last 30 minutes to one hour and participant preference will be incorporated into the HBKC intervention arm by allowing participants to prioritize the order in which curriculum topic areas will be emphasized by the CHRs. Topics from currently available NIDDK and IHS kidney education materials will include: (1) Kidney 101, (2) weight management, (3) exercise, (4) healthy eating, (5) medication management, (6) coping with stress, (7) risk factor management (i.e.- blood pressure, hyperlipidemia), (8) alcohol and substance abuse, (9) smoking cessation, and related health concerns.
Home-Based Kidney Care: All subjects randomized to the HBKC arm will be visited by a community health representative in their home at least every two weeks for the duration of the 12 month intervention. Each visit will last 30 minutes to one hour and cover materials like, (1) Kidney 101, (2) weight management, (3) exercise, (4) healthy eating, (5) medication management, (6) coping with stress, (7) risk factor management (i.e.- blood pressure, hyperlipidemia), (8) alcohol and substance abuse, (9) smoking cessation, and related health concerns.
|
|---|---|---|
|
Creatinine
Baseline
|
0.78 milligrams per deciliter
Standard Deviation 0.27
|
0.80 milligrams per deciliter
Standard Deviation 0.34
|
|
Creatinine
Change from baseline to 6 months
|
0.10 milligrams per deciliter
Standard Deviation 0.31
|
0.14 milligrams per deciliter
Standard Deviation 0.51
|
|
Creatinine
Change from baseline to 12 months
|
0.03 milligrams per deciliter
Standard Deviation 0.19
|
0.21 milligrams per deciliter
Standard Deviation 0.59
|
SECONDARY outcome
Timeframe: Baseline. Change from baseline at 6 and 12 monthsPopulation: Analysis were restricted to those who completed the KDQOL instrument.
KDQOL Short Form 12 (SF12) Physical functioning T score: normal mean=50, normal standard deviation=10. Higher values is higher quality of life.
Outcome measures
| Measure |
Usual Care / Delayed Intervention
n=73 Participants
Participants randomized to the control group will receive usual care by their provider for 12 months. They will also attend one group class taught by CHRs in which they will learn basic information about diabetes prevention. DI participants will receive publicly-available literature that reinforces the information given in class, and they will have no other contact with study staff aside from during study data collection visits at baseline and 12 months. After 12 months of usual care, patients will enter into the delayed intervention where they will complete 12 months of Home-Based Kidney Care (HBKC).
Home-Based Kidney Care: All subjects randomized to the HBKC arm will be visited by a community health representative in their home at least every two weeks for the duration of the 12 month intervention. Each visit will last 30 minutes to one hour and cover materials like, (1) Kidney 101, (2) weight management, (3) exercise, (4) healthy eating, (5) medication management, (6) coping with stress, (7) risk factor management (i.e.- blood pressure, hyperlipidemia), (8) alcohol and substance abuse, (9) smoking cessation, and related health concerns.
|
Home-Based Kidney Care Intervention
n=78 Participants
All subjects randomized to the HBKC arm will be visited by a CHR in their home at least every two weeks for the duration of the 12 month intervention. Each visit will last 30 minutes to one hour and participant preference will be incorporated into the HBKC intervention arm by allowing participants to prioritize the order in which curriculum topic areas will be emphasized by the CHRs. Topics from currently available NIDDK and IHS kidney education materials will include: (1) Kidney 101, (2) weight management, (3) exercise, (4) healthy eating, (5) medication management, (6) coping with stress, (7) risk factor management (i.e.- blood pressure, hyperlipidemia), (8) alcohol and substance abuse, (9) smoking cessation, and related health concerns.
Home-Based Kidney Care: All subjects randomized to the HBKC arm will be visited by a community health representative in their home at least every two weeks for the duration of the 12 month intervention. Each visit will last 30 minutes to one hour and cover materials like, (1) Kidney 101, (2) weight management, (3) exercise, (4) healthy eating, (5) medication management, (6) coping with stress, (7) risk factor management (i.e.- blood pressure, hyperlipidemia), (8) alcohol and substance abuse, (9) smoking cessation, and related health concerns.
|
|---|---|---|
|
SF12 Physical
Baseline
|
43.50 T score
Standard Deviation 9.88
|
44.43 T score
Standard Deviation 8.02
|
|
SF12 Physical
Change from baseline to 6 months
|
-2.07 T score
Standard Deviation 9.44
|
-0.09 T score
Standard Deviation 8.43
|
|
SF12 Physical
Change from baseline to 12 months
|
-1.18 T score
Standard Deviation 8.02
|
-1.19 T score
Standard Deviation 9.39
|
SECONDARY outcome
Timeframe: Baseline. Change from baseline at 6 and 12 monthsPopulation: Analysis were restricted to those completed the KDQOL instrument
KDQOL Short Form 12 (SF12) Mental functioning T score: normal mean=50, normal standard deviation=10. Higher values is higher quality of life.
Outcome measures
| Measure |
Usual Care / Delayed Intervention
n=73 Participants
Participants randomized to the control group will receive usual care by their provider for 12 months. They will also attend one group class taught by CHRs in which they will learn basic information about diabetes prevention. DI participants will receive publicly-available literature that reinforces the information given in class, and they will have no other contact with study staff aside from during study data collection visits at baseline and 12 months. After 12 months of usual care, patients will enter into the delayed intervention where they will complete 12 months of Home-Based Kidney Care (HBKC).
Home-Based Kidney Care: All subjects randomized to the HBKC arm will be visited by a community health representative in their home at least every two weeks for the duration of the 12 month intervention. Each visit will last 30 minutes to one hour and cover materials like, (1) Kidney 101, (2) weight management, (3) exercise, (4) healthy eating, (5) medication management, (6) coping with stress, (7) risk factor management (i.e.- blood pressure, hyperlipidemia), (8) alcohol and substance abuse, (9) smoking cessation, and related health concerns.
|
Home-Based Kidney Care Intervention
n=78 Participants
All subjects randomized to the HBKC arm will be visited by a CHR in their home at least every two weeks for the duration of the 12 month intervention. Each visit will last 30 minutes to one hour and participant preference will be incorporated into the HBKC intervention arm by allowing participants to prioritize the order in which curriculum topic areas will be emphasized by the CHRs. Topics from currently available NIDDK and IHS kidney education materials will include: (1) Kidney 101, (2) weight management, (3) exercise, (4) healthy eating, (5) medication management, (6) coping with stress, (7) risk factor management (i.e.- blood pressure, hyperlipidemia), (8) alcohol and substance abuse, (9) smoking cessation, and related health concerns.
Home-Based Kidney Care: All subjects randomized to the HBKC arm will be visited by a community health representative in their home at least every two weeks for the duration of the 12 month intervention. Each visit will last 30 minutes to one hour and cover materials like, (1) Kidney 101, (2) weight management, (3) exercise, (4) healthy eating, (5) medication management, (6) coping with stress, (7) risk factor management (i.e.- blood pressure, hyperlipidemia), (8) alcohol and substance abuse, (9) smoking cessation, and related health concerns.
|
|---|---|---|
|
SF12 Mental
Baseline
|
50.42 T score
Standard Deviation 10.90
|
51.33 T score
Standard Deviation 9.68
|
|
SF12 Mental
Change from baseline to 6 months
|
1.96 T score
Standard Deviation 9.74
|
0.47 T score
Standard Deviation 11.94
|
|
SF12 Mental
Change from baseline to 12 months
|
4.56 T score
Standard Deviation 9.88
|
2.53 T score
Standard Deviation 11.84
|
Adverse Events
Usual Care / Delayed Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Home-Based Kidney Care Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Vallabh Shah, PhD. Principal Investigator
University of New Mexico Health Sciences Center
Phone: 505-272-9615
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place