Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT04029298 |
| Other study ID # |
19-145-study 1 |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2023 |
| Est. completion date |
July 2024 |
Study information
| Verified date |
February 2023 |
| Source |
University of New Mexico |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The prevalence of overweight, obesity and T2D among American Indians (AIs) in the Albuquerque
service area of Indian Health Services (IHS) serving all pueblos in New Mexico including
Pueblo of Acoma is disproportionately elevated. Specifically, among AI, adults age 18 and
over in the IHS Albuquerque Service Area, 51% have a BMI > 30, which significantly exceeds
the rate of obesity observed nationally (35.3%) and the Healthy People 2020 target of 30.5%.
Likewise, the rate of T2D (22.8%) among the adult AI population in our Albuquerque service
area is almost double the rate of the U.S. adult population (12.2%), and the age-adjusted
diabetes mortality rate for AIs was 104.7 per 100,000 compared to 23.1 per 100,000 among
non-Hispanic Whites in the region. At the same time, the median age of diagnosis of T2D among
AI adults was much younger (42.2 years) than the national average (53.8 years).
Our major goal of implementing educational interventions to slow the current rate of increase
in diabetes in Native communities is aligned with NIH's (NIGMS) and NM INBRE's vision in
reducing health disparity using innovative interventions. The investigators propose following
aims:
Aim 1: Recruit and Screen 300 community members in Acoma Pueblo, NM to identify incident
cases of pre-diabetes for the proposed study of Home Based Diabetes Care (HBDC);
Aim 2: Enroll 150 Acoma Natives aged 21-70 years, at risk for T2D (i.e., overweight, obese,
and/or with at least one affected first degree relative or a history of gestational DM) and
conduct HBDC for a 16-week lifestyle intervention in a longitudinal cohort study. Randomize
household in a 1:1 allocation to enter either the intervention arm immediately or after a
12-month waiting list in control arm. Control participants will be treated with usual care.
Participants randomized to the waiting list will enter the intervention group 12 months after
entering the study. Both intervention groups will be followed longitudinally for total of 12
months.
Compared with people who will receive "usual care (control group)", prediabetic participants
receiving 4 months of the HBDC will exhibit improved risk factor profiles for diabetes,
obesity and heart disease, improved Patient Activation Measures, improved adherence with
medical treatment, and improved Quality of Life scores.
Description:
The investigators are conducting a prospective, randomized clinical trial of 'Home Base
Diabetes Care (HBDC)' versus usual care (delayed HBDC beginning 12 months after enrollment)
among 150 Acoma citizens with prediabetes from approximately 60 households. The household
will serve as the unit of randomization to prevent cross-contamination of the study groups.
The investigators hope to demonstrate that HBDC will result in improved patient activation
and adherence, improved health-related quality of life (HRQOL), and ultimately, improved
diabetes-related health outcomes. Standard, usual care is an appropriate comparison group
because it is widely available in Acoma through IHS and because there are a number of other
existing resources in Acoma that participants can access to achieve their healthcare goals if
they choose to do so. Improved Patient Activation may drive increased utilization of these
existing resources. The study will be non-blinded.
This is a 5-year study with screening and rolling enrollment beginning during the first year.
Participants randomized to the HBDC group will receive 16 weeks of the intervention and will
subsequently have one additional data collection visit 12 months after the intervention
(total participation approximately 16 months). Participants randomized to the usual care
group (delayed HBDC) will begin the HBDC intervention at 12 months. The intervention will be
16 weeks and a final data collection visit will be conducted 12 months after the intervention
(total participation approximately 28 months). During the HBDC intervention, both groups will
receive 8 home visits over 16 weeks (every other week) and 3 text messages per week. Data
analysis and dissemination will be conducted during the final year of the study.
The investigators will use community health representatives (CHRs) in collaboration with
licensed personnel at the University of New Mexico Health Sciences Center (UNM HSC) to
provide a comprehensive home-based intervention to prevent diabetes and improve health
through counseling around lifestyle interventions such as diet and exercise. CHRs will make
regularly scheduled home visits and they will have a lap top computer with internet access
and telemedicine contact with personnel at UNM HSC (Dr. Bouchonville, in his role as Medical
Director/Facilitator of the weekly Endo ECHO sessions) for ongoing review of care plans, and
management of prediabetes, hypertension, dyslipidemia, and kidney disease according to
current American Diabetes Association guidelines. In a collaborative manner, the participant
and healthcare team will set appropriately realistic treatment goals. Professional personnel
from UNM Clinical and Translational Science Center (e.g., physicians and bio-nutritionists)
and HSC (Endo ECHO) will serve as consultants to the primary dyad.
All subjects randomized to the HBDC arm will be visited by a CHR in their home at least every
two weeks for the duration of the 16 weeks intervention. All enrolled members of a household
unit will attend these visits. Given 25-35 households per study arm (comprising 75
participants each) and two full time CHRs working on the study, each CHR will be responsible
for approximately 15 households and up to 30 home visits per month, although this latter
estimate is high given that rolling enrollment will occur over a 2-3 year period. Each visit
will last one hour and will cover curriculum materials agreed upon by the study team and
prioritized by the participants. Other members of the household who do not have prediabetes
or who are not enrolled in the study will also be allowed to participate in the sessions if
they wish, and all subjects will be encouraged to keep their IHS appointments.
Primary outcome - To demonstrate that prediabetes risk profiles will improve with HBDC as
compared to usual care: To evaluate the effectiveness of the HBDC intervention, the
investigators will assess between-group changes in the T2D risk profile of study participants
using change in Body Mass Index and A1c as our primary outcome parameters. To reproduce
real-life community healthcare conditions, A1c will be assessed in both study groups with POC
as an indicator of 90 day glucose homeostasis. BMI will be determined using a SECA 876 Floor
Scale (SECA Inc., Chino, CA), and height will be assessed using SECA 217 Portable Stadiometer
with floor scale adapter. Study participants in the intervention arm will be counseled to
lose 5% of their body weight over the course of the 12-month study. This is a reasonable
weight-loss goal based on the following: (1) in our previous extended family-based studies,
45.9% were obese, and all of the randomized participants will have BMI >27 kg/m2; (2) in our
previous study, participants in the lifestyle intervention successfully met weight goals over
a relatively short period of time; and (3) eliminating or expending enough energy to burn 500
calories/day, while making no other changes, will result in a weight loss of up to 0.5 kg per
week.
Biological variables include: (a) T2D incidence determined at each outcome assessment
according to the criteria established by the American Diabetes Association (FPG ≥ 126 mg/dL
and/or A1c > 6.4%); (b) Waist-to-hip ratio following the protocol used in the Diabetes
Prevention Program; (c) Fasting blood glucose (i-STAT system, Abbott Laboratories, Princeton,
NJ); (d) Blood pressure determined using 2 measures after 5 minutes of sitting using an
electronic implement (Prestige Medical, Northridge CA); and (e) Fasting lipid panel (HDL,
LDL, total cholesterol, and triglycerides) at baseline, 16 weeks, and 16 months (HBDC group)
and baseline, 12 months, 16 months, and 28 months (Usual Care/delayed HBDC group). Dietary
change will be assessed by comparing the results of a food frequency questionnaire (FFQ) from
baseline to month 12 and at post-intervention follow-up. The study will use a FFQ developed
for and validated in American Indians. Participants in the intervention arm will be asked to
complete a three-day food record once per month over the three days before the next home
visit. Weekly activity logs, as well as pedometer data, will be collected over a one week
period prior to assessment at 0, 8, and 16 weeks.
Secondary outcomes: The PAM is the secondary outcome variable of Aim 2, and a PAM score will
be obtained at 0, 6, and 12 weeks and at 12 month follow-up in all participants. In all
cases, data will be collected within a two week window of the target date, except for the 12
month post-intervention time point, which will occur within a one month window of the 12
month target date. The investigators will use a short version of PAM using a 13-item survey
tool designed to assess a person's knowledge, skill, and confidence in managing his or her
own healthcare. The response options for the 13 PAM questions use a categorical agreement
scale with 4 response options: (i) strongly disagree, (ii) disagree, (iii) agree, (iv)
strongly agree, and N/A. The raw score will be calculated by adding responses to the 13
questions. If all questions are answered (i.e., no "N/A" is used), the range of raw scores
would be 13 to 52. If there is at least 1 item with a response of N/A, the total score will
be divided by the number of items completed and multiplied by 13 to yield a normalized raw
score. A nomogram provided by Dr. Hibbard converts raw scores to an "activation score,"
ranging from 0 to 100. Activation score cut points derived from Dr. Hibbard's preliminary
data will assign participants into 1 of 4 stages of progressive activation: (i) believes an
active role is important; (ii) has the confidence and knowledge to take action; (iii) is
taking action; and (iv) is able to maintain course under stress. The survey has been fully
developed and validated. Higher PAM scores are associated with healthy behaviors, a higher
likelihood of practicing self-management behaviors, and higher medication adherence. Patients
scoring at the lower end of the activation scale may believe that the physician is the one to
"fix" them, while mid-range scores indicate that patients recognize that they must be
involved in their care but lack the knowledge to do so effectively. Patients with high PAM
scores possess confidence in their ability to self-manage and make healthy changes. Thus,
progression in PAM score is an ideal indicator to reflect improvement in health literacy,
self-efficacy, and self-determination among at-risk, health-disparate peoples such as the
Acoma. In Aim 2, the investigators will demonstrate that participants in the HBDC group will
advance at least one level in activation as compared to participants in the control group.
Adherence to treatment is another secondary outcome of Aim 2. Although adherence can be
difficult to measure in a community based study such as this, the investigators will employ a
comprehensive approach to informing patients about the importance of their treatment plans
and to assessing adherence by combining education with behavior modification strategies (24).
Indicators of adherence will include pill counts, process-oriented information (refill
records), sessions attended, appointments kept, and diet and activity log books kept. For the
purposes of data analysis, the investigators have devised a simple three-point system for
determining adherence. Participants will receive one point for each of three benchmarks
achieved: (a) >80% of prescribed medications taken over the past 30 days (medications counted
will include anti-hypertensive medications, lipid-lowering medications, and glucose lowering
medications); (b) >80% of all health-related appointments kept during the past six months;
and (c) 100% of activity log books kept over the past two weeks. Data on "appointments kept"
will include a composite of scheduled IHS clinic appointments.
