NCT05534607|RecruitingDMC
Natives Engaged in Alzheimers Research - 'Ike Kupuna
NEAR
Loading search results
NEAR
Sponsor study identifier
interventional
192
1 country
3
Study Start
September 15, 2022
Actual (reported)Primary Completion
June 15, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
April 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 12, 2022
Actual (reported)September 9, 2022
Actual (reported)September 15, 2022
Actual (reported)June 15, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
April 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Change in participants' systolic blood pressure at each time frame from baseline
Vascular risk factor assessed using Omron©HEM-907XL
3 months, 8 months, 12 months
Change in participants' Hemoglobin A1c at each time frame from baseline
Vascular risk factor assessed using Alere Cholestech LDX® System
12 months
Change in participants' total cholesterol at each time frame from baseline
Vascular risk factor assessed using Alere Cholestech LDX® System
3 months, 8 months, 12 months
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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Kula No Na Po'e
Honolulu, Hawaii, 96813, United States
Kokua Kalihi Valley
Honolulu, Hawaii, 96819, United States
Joseph K Kaholokula, PhD
University of Hawaii
First Submitted
August 12, 2022
First Posted
September 9, 2022
Study Start
September 15, 2022
Actual (reported)Primary Completion
Computerized Memory Enhancing Treatment in MCI
Change in participants' body mass index at each time frame from baseline
Vascular risk factor assessed using Tanita BWB800AS scale
3 months, 8 months, 12 months
Change in participants' Cognitive Change Index score at each time frame from baseline
Cognitive function assessed using Cognitive Change Index assessment
3 months, 8 months, 12 months
Change in participants' Number Symbol Coding Test score at each time frame from baseline
Cognitive function assessed using Number Symbol Coding Test
3 months, 8 months, 12 months
Change in participants' overall Cognivue score at each time frame from baseline
Cognitive function assessed using Cognivue device
3 months, 8 months, 12 months
Change in participants' overall Quick Dementia Rating System score at each time frame from baseline
Cognitive function assessed using Quick Dementia Rating System assessment
3 months, 8 months, 12 months
Contact the study team to confirm eligibility.
Hui No Ke Ola Pono
Wailuku, Hawaii, 96793, United States
June 15, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
April 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
August 1, 2024
Record last verified: 2024-07
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: