Type 2 DiabetesNCT02320344
Partnerships to Improve Lifestyle Interventions (PILI) 'Ohana Dissemination Project Partners in Care
A study testing Partners in Care in people with Type 2 Diabetes, run by University of Hawaii at 1 site in United States.
Trial summary
The 3-month face-to-face Partners in Care intervention will be community-based and community-led by trained community peer educators from these four partnering community organizations. The intervention involves 12 weekly, group lessons with each lesson lasting about 1 and 1/2 hours. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Partners in Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Dec 2017
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults age >18 years of age,
- English-speaking,
- Physician-diagnosed type 2 diabetes, and
- Baseline hemoglobin A1c >7%.
Who cannot join
- Survival less than 6 months,
- Planning to move out of the community during the intervention study period,
- Pregnancy,
- Any co-morbid condition (physical and mental disabilities) that would prevent the individual from participating in the intervention protocol (i.e., major psychiatric illness).
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Native Hawaiian Health, University of Hawaii
Honolulu, Hawaii, 96813
About this study
The 3-month face-to-face Partners in Care intervention will be community-based and community-led by trained community peer educators from these four partnering community organizations. The intervention involves 12 weekly, group lessons with each lesson lasting about 1 and 1/2 hours. Individuals with a hemoglobin A1c (HbA1c; average blood sugar levels) greater than or equal to 7% will be recruited for the study because they represent the most at-risk for diabetes-related complications. Over a 3-year accrual period, the community partners will recruit and enroll 150 eligible NHs and PPs, as well as deliver and evaluate the intervention in their respective community settings. The primary outcomes of our study are hemoglobin A1c and self-reported diabetes specific quality of life. Secondary outcomes are cholesterol levels (including HDL, LDL, total cholesterol, and triglycerides), blood pressure, body mass index, and psychosocial adaptation.
- Conditions
- Type 2 Diabetes
- Being tested
- Partners in Care
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Partners in CareBehavioural
The diabetes self-management intervention is titled, "Partners in Care," emphasizing that there are many individuals and groups that one can call upon to assist with managing one's diabetes. The content includes practical behavioral strategies to improve diabetes self-management practices. The 12 week curriculum provides a basic overview of diabetes and self-management activities, standards of care recommended by the American Diabetes Association, strategies to improve patient-provider communication, support needed for diabetes self-management, information about diabetes medications, and ways to avoid diabetes-related complications.
| Study group | Role | What they receive |
|---|---|---|
| Partners in Care | Experimental | Not described Receives: Behavioral: Partners in Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin A1c
change in hemoglobin A1c from baseline to 3-months
Measured: 3 months
Problem Areas in Diabetes
The Problem Areas in Diabetes (PAID) will be used to assess diabetes specific quality of life. Change in PAID score from baseline to 3-months
Measured: 3 months
Secondary outcomes (2)
Total Cholesterol (including HDL and LDL)
change in cholesterol from baseline to 3 months
Measured: 3 months
Triglycerides
change in triglycerides from baseline to 3 months
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2014 (estimated)
- Study startJul 2013
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Hawaii
- Sponsor type
- University, hospital or other
- Collaborators
- Kula No Na Po'e Hawaii, Ke Ola Mamo, Hawai'i Maoli, Kokua Kalihi Valley
- Responsible party
- Principal investigator, Joseph Keawe'aimoku Kaholokula, University of Hawaii
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02320344
- Sponsor's protocol ID
- MD001660 - PIC
- Status last verified
- Oct 2017
- First submitted
- 16 Dec 2014
- Last updated
- 3 May 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Partnerships to Improve Lifestyle Interventions (PILI) 'Ohana Dissemination Project Partners in Care
- ClinicalTrials.gov ID
- NCT02320344
- Acronym / sponsor ID
- MD001660 - PIC
- Conditions
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- University of HawaiiUniversity, hospital or other
- Collaborators
- Kula No Na Po'e Hawaii, Ke Ola Mamo, Hawai'i Maoli, Kokua Kalihi Valley
- Study start
- Jul 2013
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 19 Dec 2014 (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.
The 3-month face-to-face Partners in Care intervention will be community-based and community-led by trained community peer educators from these four partnering community organizations. The intervention involves 12 weekly, group lessons with each lesson lasting about 1 and 1/2 hours. Individuals with a hemoglobin A1c (HbA1c; average blood sugar levels) greater than or equal to 7% will be recruited for the study because they represent the most at-risk for diabetes-related complications. Over a 3-year accrual period, the community partners will recruit and enroll 150 eligible NHs and PPs, as well as deliver and evaluate the intervention in their respective community settings. The primary outcomes of our study are hemoglobin A1c and self-reported diabetes specific quality of life. Secondary outcomes are cholesterol levels (including HDL, LDL, total cholesterol, and triglycerides), blood pressure, body mass index, and psychosocial adaptation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Partners in Care | Experimental | Behavioral: Partners in Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults age >18 years of age,
- English-speaking,
- Physician-diagnosed type 2 diabetes, and
- Baseline hemoglobin A1c >7%.
Key exclusion criteria (4 listed)
- Survival less than 6 months,
- Planning to move out of the community during the intervention study period,
- Pregnancy,
- Any co-morbid condition (physical and mental disabilities) that would prevent the individual from participating in the intervention protocol (i.e., major psychiatric illness).
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 |
|---|---|---|
| Partners in CareThe diabetes self-management intervention is titled, "Partners in Care," emphasizing that there are many individuals and groups that one can call upon to assist with managing one's diabetes. The content includes practical behavioral strategies to improve diabetes self-management practices. The 12 week curriculum provides a basic overview of diabetes and self-management activities, standards of care recommended by the American Diabetes Association, strategies to improve patient-provider communication, support needed for diabetes self-management, information about diabetes medications, and ways to avoid diabetes-related complications. | Behavioural | Partners in Care |
Primary outcome
Hemoglobin A1c
Time frame: 3 months
change in hemoglobin A1c from baseline to 3-months
Problem Areas in Diabetes
Time frame: 3 months
The Problem Areas in Diabetes (PAID) will be used to assess diabetes specific quality of life. Change in PAID score from baseline to 3-months
2 secondary outcomes
Total Cholesterol (including HDL and LDL)
Time frame: 3 months
Triglycerides
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Partners in Care in people with Type 2 Diabetes, run by University of Hawaii at 1 site in United States.
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 4 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: finished, as of the sponsor's last update on 3 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Hemoglobin A1c (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 May 2018.