Back to resultsNatives Engaged in Alzheimers Research - 'Ike Kupuna (NEAR)
Primary Purpose
Mild Cognitive Impairment, Subjective Cognitive Impairment
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ola Mau i ka Hula
Sponsored by
About this trial
This is an interventional prevention trial for Mild Cognitive Impairment focused on measuring MCI, Alzheimer's disease, Alzheimer's disease and related dementias, Vascular dementia, ADRD, SCI, Native Hawaiian and Pacific Islander, NHPI, Hula, cultural based intervention, behavioral intervention
Eligibility Criteria
Inclusion Criteria:
- self-reported Native Hawaiian or other Pacific Islander ancestry;
- ages 50+ but not older than 75 (optimal age range for preventing future dementia in people with cognitive impairment, above 75 is not likely to benefit from this study given their advance age);
- has subjective cognitive impairment (SCI) or mild cognitive impairment (MCI);
- have a diagnosis of hypertension, diabetes, dyslipidemia, or obesity (body-mass-index ≥ 30 kg/m2);
- physically able and willing to engage in moderate physical activity necessary for Hula; and
- physician's approval to participate in moderate physical activity
Exclusion Criteria:
- currently pregnant;
- already actively practicing Hula at least once per week; or
- clinical diagnosis of ADRD (mild to severe); or
- current diagnosed major depressive disorder at moderate or greater stage, or moderate or greater depression on the Center for Epidemiological Studies Depression Scale (CES-D).
Sites / Locations
- Kula No Na Po'eRecruiting
- Kokua Kalihi ValleyRecruiting
- Hui No Ke Ola PonoRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention group
Wait-list control group
Arm Description
The intervention group will immediately receive the Ola Mau i ka Hula intervention after randomization for 12 months. The intervention program is 8 months with a 4 month self-monitoring period.
After baseline data collection, participants randomized to the wait-list control arm will not receive the Ola Mau i ka Hula Program while their counterparts who were randomized to the intervention arm are undergoing the intervention program. Thus, they will not be offered the intervention until after the intervention arm is completed and their 12-month follow-up data collection is completed. They will only receive the educational component of the intervention from us during this 12-month period but they will be instructed to continue with their routine medical care as usual. Wait-list control group will be offered the opportunity to receive intervention at the conclusion of 12 month assessment period, regardless of whether they were retained for the full 12 months of data collection.
Outcomes
Primary Outcome Measures
Change in participants' systolic blood pressure at each time frame from baseline
Vascular risk factor assessed using Omron©HEM-907XL
Change in participants' Hemoglobin A1c at each time frame from baseline
Vascular risk factor assessed using Alere Cholestech LDX® System
Change in participants' total cholesterol at each time frame from baseline
Vascular risk factor assessed using Alere Cholestech LDX® System
Change in participants' body mass index at each time frame from baseline
Vascular risk factor assessed using Tanita BWB800AS scale
Change in participants' Cognitive Change Index score at each time frame from baseline
Cognitive function assessed using Cognitive Change Index assessment
Change in participants' Number Symbol Coding Test score at each time frame from baseline
Cognitive function assessed using Number Symbol Coding Test
Change in participants' overall Cognivue score at each time frame from baseline
Cognitive function assessed using Cognivue device
Change in participants' overall Quick Dementia Rating System score at each time frame from baseline
Cognitive function assessed using Quick Dementia Rating System assessment
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05534607
Brief Title
Natives Engaged in Alzheimers Research - 'Ike Kupuna
Acronym
NEAR
Official Title
Natives Engaged in Alzheimers Research - 'Ike Kupuna (Elder Wisdom) Project
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 15, 2022 (Actual)
Primary Completion Date
April 30, 2025 (Anticipated)
Study Completion Date
April 30, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Hawaii
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study will conduct a group randomized trial to test the effects of a hula-based intervention in improving vascular risk factors for ADRD and cognitive complaints and function over 12 months.
Detailed Description
This study will conduct a pragmatic group-randomized trial (GRT) with NHPIs aged 50-75 years with at least 1 of 4 modifiable vascular risk factors for ADRD (hypertension, hyperglycemia, obesity, or dyslipidemia) and either SCI or MCI using a wait-list control design to test the effects of the hula-based intervention. The primary outcomes will be vascular risk factors for ADRD and subjective cognitive complaints. Secondary outcomes will include measures of cognitive performance, physical function, and mental health.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment, Subjective Cognitive Impairment
Keywords
MCI, Alzheimer's disease, Alzheimer's disease and related dementias, Vascular dementia, ADRD, SCI, Native Hawaiian and Pacific Islander, NHPI, Hula, cultural based intervention, behavioral intervention
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study uses a wait list control design, where the wait-list control group is offered the intervention at the completion of the intervention group's 12-month intervention and assessment period.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
192 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
The intervention group will immediately receive the Ola Mau i ka Hula intervention after randomization for 12 months. The intervention program is 8 months with a 4 month self-monitoring period.
Arm Title
Wait-list control group
Arm Type
No Intervention
Arm Description
After baseline data collection, participants randomized to the wait-list control arm will not receive the Ola Mau i ka Hula Program while their counterparts who were randomized to the intervention arm are undergoing the intervention program. Thus, they will not be offered the intervention until after the intervention arm is completed and their 12-month follow-up data collection is completed. They will only receive the educational component of the intervention from us during this 12-month period but they will be instructed to continue with their routine medical care as usual.
Wait-list control group will be offered the opportunity to receive intervention at the conclusion of 12 month assessment period, regardless of whether they were retained for the full 12 months of data collection.
Intervention Type
Behavioral
Intervention Name(s)
Ola Mau i ka Hula
Other Intervention Name(s)
Ola Mau
Intervention Description
The first 3 months of the hula-based intervention program was designed and standardized as a culturally-based physical activity (PA) that includes 15 minutes of ADRD education and intervention orientation with 12 weeks of hula lessons.
These hula lessons consist of two 60-minute classes per week over 12 weeks. Each hula lesson will consist of 8 participants, providing them with the opportunity to engage-in this social support network.
For the remaining 5 months of the Ola Mau i ka Hula Program, hula lessons led by the kumu hula will be reduced to once a month for 60 min. In addition, the intervention group will meet with a community-peer educator weekly over this 5-month period. Each meeting will be 90 minutes in length with 60 minutes of hula practice following the same format as previous classes, and 30 minutes will cover the PILI Lifestyle Plan curriculum and cultural-based cognitive exercises, alternating weekly.
Primary Outcome Measure Information:
Title
Change in participants' systolic blood pressure at each time frame from baseline
Description
Vascular risk factor assessed using Omron©HEM-907XL
Time Frame
3 months, 8 months, 12 months
Title
Change in participants' Hemoglobin A1c at each time frame from baseline
Description
Vascular risk factor assessed using Alere Cholestech LDX® System
Time Frame
12 months
Title
Change in participants' total cholesterol at each time frame from baseline
Description
Vascular risk factor assessed using Alere Cholestech LDX® System
Time Frame
3 months, 8 months, 12 months
Title
Change in participants' body mass index at each time frame from baseline
Description
Vascular risk factor assessed using Tanita BWB800AS scale
Time Frame
3 months, 8 months, 12 months
Title
Change in participants' Cognitive Change Index score at each time frame from baseline
Description
Cognitive function assessed using Cognitive Change Index assessment
Time Frame
3 months, 8 months, 12 months
Title
Change in participants' Number Symbol Coding Test score at each time frame from baseline
Description
Cognitive function assessed using Number Symbol Coding Test
Time Frame
3 months, 8 months, 12 months
Title
Change in participants' overall Cognivue score at each time frame from baseline
Description
Cognitive function assessed using Cognivue device
Time Frame
3 months, 8 months, 12 months
Title
Change in participants' overall Quick Dementia Rating System score at each time frame from baseline
Description
Cognitive function assessed using Quick Dementia Rating System assessment
Time Frame
3 months, 8 months, 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
self-reported Native Hawaiian or other Pacific Islander ancestry;
ages 50+ but not older than 75 (optimal age range for preventing future dementia in people with cognitive impairment, above 75 is not likely to benefit from this study given their advance age);
has subjective cognitive impairment (SCI) or mild cognitive impairment (MCI);
have a diagnosis of hypertension, diabetes, dyslipidemia, or obesity (body-mass-index ≥ 30 kg/m2);
physically able and willing to engage in moderate physical activity necessary for Hula; and
physician's approval to participate in moderate physical activity
Exclusion Criteria:
currently pregnant;
already actively practicing Hula at least once per week; or
clinical diagnosis of ADRD (mild to severe); or
current diagnosed major depressive disorder at moderate or greater stage, or moderate or greater depression on the Center for Epidemiological Studies Depression Scale (CES-D).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Janice K Worthington, MPH
Phone
8086921023
Email
ikekupuna@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph K Kaholokula, PhD
Organizational Affiliation
University of Hawaii
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kula No Na Po'e
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adrienne Dillard, PhD
Phone
808-692-1023
Email
ikekupuna@gmail.com
Facility Name
Kokua Kalihi Valley
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96819
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sheryl Yoshimura, RD
Phone
808-692-1023
Email
ikekupuna@gmail.com
Facility Name
Hui No Ke Ola Pono
City
Wailuku
State/Province
Hawaii
ZIP/Postal Code
96793
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Malia Purdy, PhD
Phone
808-692-1023
Email
ikekupuna@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Natives Engaged in Alzheimers Research - 'Ike Kupuna
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