DiabetesZHI-CDENCT02339311
Zuni Health Initiative - Chronic Disease Education
An observational study of Diabetes, run by University of New Mexico.
Trial summary
One in three people will be diagnosed with diabetes by 2050, and the proportion will likely be higher among Native Americans. Diabetes control is currently suboptimal in underserved populations such as Zuni Indians despite a plethora of new therapies. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Diabetes
- What is being tested?
- Educational intervention of Lifestyle and patient activation in diabetics
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jun 2012to Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study population is Zuni diabetics with HbA1c level of 6.6% and above in the age range of 21 yrs to 75 yrs old lining in Zuni Pueblo.
Who may be able to join
- Diabetes with HbA1c greater than 6.6%
- Zuni Native only
- Age 21-75 yrs
- on diabetes medication
Who cannot join
- Non-Zuni Native
- Non-diabetic
- Not able to consent
About this study
Official title: A Home-based Educational Intervention Improves Patient Activation Measures and Diabetes Health Indicators Among Zuni Indians
One in three people will be diagnosed with diabetes by 2050, and the proportion will likely be higher among Native Americans. Diabetes control is currently suboptimal in underserved populations such as Zuni Indians despite a plethora of new therapies. Patient empowerment is a key determinant of diabetes control, but such empowerment can be difficult to achieve due to resource limitation and cultural, language and health literacy barriers. The investigators will conduct a home-based chronic disease (diabetes) educational intervention using Community Health Representatives (CHRs) to associate improvement in Patient Activation Measures scores (primary outcome) and clinical indicators of diabetes control (secondary outcomes).
Read the detailed description
The number of American Indians and Alaska Natives (AI/ANs) who have diabetes is growing rapidly, especially among young people. At more than 16%, AI/ANs have the highest age-adjusted prevalence of diabetes among all U.S. racial and ethnic groups [1]. One such population is the Zuni Pueblo home to a small, geographically isolated tribe located in a rural portion of New Mexico, USA. It is home to ~11,000 Zuni Indians and over 90% of all Zunis live in the Pueblo. This socioeconomically disadvantaged population faces a major public health challenge from growing health disparities. Changing lifestyles have led to decreased physical activity and increased caloric intake with high consumption of fast food, soda pop and alcohol. Therefore, the Zuni are experiencing interrelated epidemics of obesity, diabetes, hypertension, kidney disease and intermediate phenotypes.
As part of the Zuni Health Initiative (ZHI), the investigators surveyed participants regarding barriers to healthcare [2], with particular attention to diabetes care. In ZHI the investigators also collected and stored clinical phenotype information and anthropological measurements from all participants. Participants identified the following barriers: access to care, language barriers, limited patient education, and anxiety around diagnosis, fear of chronic disease, reluctance to participate in self-care, resistance to dietary change, and reluctance to engage in regular exercise. The investigators have previously documented suboptimal glycemic control with a high burden of kidney disease among the Zuni [3, 4]. The burden presented by these barriers ultimately translates into a lack of patient activation and engagement in their healthcare, effectively hindering adoption of healthy behaviors. Focus groups subsequently identified common solutions to overcome some of these barriers, including home-based care, point of care testing, individualized exercise and nutrition prescriptions, and care providers with knowledge of the Zuni language, community and culture.
The information gathered during these focus groups [5] is used to design and implement a Zuni culture specific educational intervention in diabetes. The investigators have devised an innovative educational intervention based on the coordination of four key elements: (a) delivering healthcare that incorporated collaborative communication within the healthcare team and emphasized greater autonomy in care, adherence to the medical regimen, and patient-centered goal setting, all while retaining the ability to address the needs of patients, family members, the healthcare team, and/or the healthcare system; (b) providing innovative educational and organizational approaches, as well as behavior change strategies, that enhanced adherence; (c) addressing health beliefs that reduced adherence by over- or under-predicting maladaptive thoughts (e.g., catastrophizing, minimizing, cognitive dissonance, invincibility, or fatalism) or that interfered with weight control; and (d) using technology to address barriers to achieving desired health outcomes.
Sixty participants with type 2 diabetes (T2D) completed a baseline evaluation including physical exam, Point of Care (POC) testing, and the Patient Activation Measure (PAM) survey. Participants then underwent a one hour group didactic session led by Community Health Representatives (CHRs) who subsequently carried out monthly home-based educational interventions to encourage healthy lifestyles, including diet, exercise, and alcohol and cigarette avoidance until follow up at 6 months, when clinical phenotyping and the PAM survey were repeated.
- Conditions
- Diabetes
- Being tested
- Educational intervention of Lifestyle and patient activation in diabetics
- Keywords
- The study focus is on lifestyle changes and patient activation in diabetic patients by regular monthly visit by the CHRs
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational intervention of Lifestyle and patient activation in diabeticsOther
Participants underwent a one hour group didactic session led by Community Health Representatives (CHRs) who subsequently carried out monthly home-based educational interventions to encourage healthy lifestyles, including diet, exercise, and alcohol and cigarette avoidance until follow up at 6 months, when clinical phenotyping and the PAM survey were repeated.
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Activation
The Patient Activation Measure (PAM) instrument completed by participants using the short form PAM questionnaire [16, 17]. The response options for the 13 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 is 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. All study procedures were repeated 6-months later, following the intervention.
Measured: 6 months
Secondary outcomes (1)
Diabetes associated health indicators
HbA1c, Glucose, Lipids, BMI
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2015 (estimated)
- Study startJun 2012
- Primary completionJun 2012
- Study completionDec 2012
Why it stopped: This is not a clinical trial and was inadvertently entered into the system.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vallabh Shah, PhD, Principal investigator, University of New Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02339311
- Sponsor's protocol ID
- 10-249
- Acronym
- ZHI-CDE
- Status last verified
- Jan 2024
- First submitted
- 12 Jan 2015
- Last updated
- 10 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Shah VO, Carroll C, Mals R, Ghahate D, Bobelu J, Sandy P, Colleran K, Schrader R, Faber T, Burge MR. A Home-Based Educational Intervention Improves Patient Activation Measures and Diabetes Health Indicators among Zuni Indians. PLoS One. 2015 May 8;10(5):e0125820. doi: 10.1371/journal.pone.0125820. eCollection 2015.
PubMed 25954817
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Home-based Educational Intervention Improves Patient Activation Measures and Diabetes Health Indicators Among Zuni Indians
- ClinicalTrials.gov ID
- NCT02339311
- Acronym / sponsor ID
- ZHI-CDE / 10-249
- Conditions
- Diabetes
- Keywords
- The study focus is on lifestyle changes and patient activation in diabetic patients by regular monthly visit by the CHRs
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: This is not a clinical trial and was inadvertently entered into the system.
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Study start
- Jun 2012 (actual)
- Primary completion
- Jun 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 15 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
One in three people will be diagnosed with diabetes by 2050, and the proportion will likely be higher among Native Americans. Diabetes control is currently suboptimal in underserved populations such as Zuni Indians despite a plethora of new therapies. Patient empowerment is a key determinant of diabetes control, but such empowerment can be difficult to achieve due to resource limitation and cultural, language and health literacy barriers. The investigators will conduct a home-based chronic disease (diabetes) educational intervention using Community Health Representatives (CHRs) to associate improvement in Patient Activation Measures scores (primary outcome) and clinical indicators of diabetes control (secondary outcomes).
Detailed description
The number of American Indians and Alaska Natives (AI/ANs) who have diabetes is growing rapidly, especially among young people. At more than 16%, AI/ANs have the highest age-adjusted prevalence of diabetes among all U.S. racial and ethnic groups [1]. One such population is the Zuni Pueblo home to a small, geographically isolated tribe located in a rural portion of New Mexico, USA. It is home to ~11,000 Zuni Indians and over 90% of all Zunis live in the Pueblo. This socioeconomically disadvantaged population faces a major public health challenge from growing health disparities. Changing lifestyles have led to decreased physical activity and increased caloric intake with high consumption of fast food, soda pop and alcohol. Therefore, the Zuni are experiencing interrelated epidemics of obesity, diabetes, hypertension, kidney disease and intermediate phenotypes.
As part of the Zuni Health Initiative (ZHI), the investigators surveyed participants regarding barriers to healthcare [2], with particular attention to diabetes care. In ZHI the investigators also collected and stored clinical phenotype information and anthropological measurements from all participants. Participants identified the following barriers: access to care, language barriers, limited patient education, and anxiety around diagnosis, fear of chronic disease, reluctance to participate in self-care, resistance to dietary change, and reluctance to engage in regular exercise. The investigators have previously documented suboptimal glycemic control with a high burden of kidney disease among the Zuni [3, 4]. The burden presented by these barriers ultimately translates into a lack of patient activation and engagement in their healthcare, effectively hindering adoption of healthy behaviors. Focus groups subsequently identified common solutions to overcome some of these barriers, including home-based care, point of care testing, individualized exercise and nutrition prescriptions, and care providers with knowledge of the Zuni language, community and culture.
The information gathered during these focus groups [5] is used to design and implement a Zuni culture specific educational intervention in diabetes. The investigators have devised an innovative educational intervention based on the coordination of four key elements: (a) delivering healthcare that incorporated collaborative communication within the healthcare team and emphasized greater autonomy in care, adherence to the medical regimen, and patient-centered goal setting, all while retaining the ability to address the needs of patients, family members, the healthcare team, and/or the healthcare system; (b) providing innovative educational and organizational approaches, as well as behavior change strategies, that enhanced adherence; (c) addressing health beliefs that reduced adherence by over- or under-predicting maladaptive thoughts (e.g., catastrophizing, minimizing, cognitive dissonance, invincibility, or fatalism) or that interfered with weight control; and (d) using technology to address barriers to achieving desired health outcomes.
Sixty participants with type 2 diabetes (T2D) completed a baseline evaluation including physical exam, Point of Care (POC) testing, and the Patient Activation Measure (PAM) survey. Participants then underwent a one hour group didactic session led by Community Health Representatives (CHRs) who subsequently carried out monthly home-based educational interventions to encourage healthy lifestyles, including diet, exercise, and alcohol and cigarette avoidance until follow up at 6 months, when clinical phenotyping and the PAM survey were repeated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study population is Zuni diabetics with HbA1c level of 6.6% and above in the age range of 21 yrs to 75 yrs old lining in Zuni Pueblo.
Key inclusion criteria (4 listed)
- Diabetes with HbA1c greater than 6.6%
- Zuni Native only
- Age 21-75 yrs
- on diabetes medication
Key exclusion criteria (3 listed)
- Non-Zuni Native
- Non-diabetic
- Not able to consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational intervention of Lifestyle and patient activation in diabeticsParticipants underwent a one hour group didactic session led by Community Health Representatives (CHRs) who subsequently carried out monthly home-based educational interventions to encourage healthy lifestyles, including diet, exercise, and alcohol and cigarette avoidance until follow up at 6 months, when clinical phenotyping and the PAM survey were repeated. | Other | – |
Primary outcome
Patient Activation
Time frame: 6 months
The Patient Activation Measure (PAM) instrument completed by participants using the short form PAM questionnaire [16, 17]. The response options for the 13 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 is 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. All study procedures were repeated 6-months later, following the intervention.
1 secondary outcome
Diabetes associated health indicators
Time frame: six months
Results and safety
The study was stopped early (reason given: This is not a clinical trial and was inadvertently entered into the system.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2024.
- Derived from this study: PubMed 25954817Shah VO, Carroll C, Mals R, Ghahate D, Bobelu J, Sandy P, Colleran K, Schrader R, Faber T, Burge MR. A Home-Based Educational Intervention Improves Patient Activation Measures and Diabetes Health Indicators among Zuni Indians. PLoS One. 2015 May 8;10(5):e0125820. doi: 10.1371/journal.pone.0125820. eCollection 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vallabh Shah, PhD principal investigator
University of New Mexico
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes, run by University of New Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: This is not a clinical trial and was inadvertently entered into the system.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Activation (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02339311, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2024.