Diabetes Mellitus, Type 2NCT02144909
Partners in Care With Semi-Structured Support Group
A study testing Partners in Care with Semi-Structured Support Group in people with Diabetes Mellitus, Type 2, run by University of Hawaii at 3 sites in United States.
Trial summary
The investigators are conducting a feasibility study using a randomized controlled trial (RCT) design in which participants will receive the Partners in Care (PIC) diabetes self-management intervention and then be randomized to either semi-structured social support or a standard follow-up control group. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Partners in Care with Semi-Structured Support Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 3 sitesUnited States
- Study dates
- Nov 2013to Sep 2014
- 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
- Self-reported Native Hawaiian, Filipino, or other Pacific Islander ethnic background
- Adults age >18 years of age
- English-speaking
- Physician-diagnosed type 2 diabetes
- Baseline hemoglobin A1c >8%
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
3 sites in 1 country.
United States3 sites
Kula no na Po'e Hawai'i
Honolulu, Hawaii, 96813
Ke Ola Mamao
Honolulu, Hawaii, 96817
Kokua Kalihi Valley
Honolulu, Hawaii, 96819
About this study
The investigators are conducting a feasibility study using a randomized controlled trial (RCT) design in which participants will receive the Partners in Care (PIC) diabetes self-management intervention and then be randomized to either semi-structured social support or a standard follow-up control group. Participants in the support groups will receive a culturally-tailored, semi-structured social support program delivered in a community setting by trained community peer educators and other health professionals (e.g., pharmacist). The investigators believe that the addition of a semi-structured social support component as a supplement to an evidence-based diabetes self-management intervention will improve diabetes self-care maintenance.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Partners in Care with Semi-Structured Support Group
- Keywords
- Diabetes self management, support group, semi structured support group
- 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 Care with Semi-Structured Support GroupBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Partners in Care with Semi-Structured Support Group | Experimental | Partners in Care with Semi-Structured Support Group: participants will receive the Partners in Care intervention followed by 6 semi-structured support groups, conducted every other week for 3 months. Half of the support groups will be conducted by professionals with diabetes specific knowledge, e.g., pharmacists, physicians, nutritionists. While the other half will be conducted by the trained diabetes self-management facilitator. Receives: Behavioral: Partners in Care with Semi-Structured Support Group |
| Partners in Care Standard Follow-up | No intervention | Participants will receive the Partners in Care intervention followed by monthly healthy lifestyle tips related to diabetes self-management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline hemoglobin a1c at 3 months and at 6 months
Measured: baseline, 3 months, 6 months
Change from Baseline diabetes management functioning as measured by the Problem Areas in Diabetes questionnaire at 3 months and 6 months
The PAID is a 20-item instrument that assesses the physical and social functioning of patients as well as their perceived level of mental and emotional well-being specific to living with diabetes.
Measured: baseline, 3 months, 6 months
Secondary outcomes (3)
Change from Baseline blood pressure at 3 months and 6 months
Measured: baseline, 3 months, 6 months
Change from Baseline Total Cholesterol (including HDL and LDL) and triglycerides at 3 months and 6 months
Total Cholesterol (including HDL and LDL) and triglycerides will be measured with the Cholestech LDX analyzer
Measured: baseline, 3 months, 6 months
Change from Baseline weight in kg at 3 months and 6 months
Measured: baseline, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2014 (estimated)
- Study startNov 2013
- Primary completionJul 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Hawaii
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Claire Townsend, University of Hawaii
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02144909
- Sponsor's protocol ID
- CHS-21514
- Other IDs
- U54MD007584
- Status last verified
- Jun 2015
- First submitted
- 15 Nov 2013
- Last updated
- 3 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Sinclair KA, Makahi EK, Shea-Solatorio C, Yoshimura SR, Townsend CK, Kaholokula JK. Outcomes from a diabetes self-management intervention for Native Hawaiians and Pacific People: Partners in Care. Ann Behav Med. 2013 Feb;45(1):24-32. doi: 10.1007/s12160-012-9422-1.
PubMed 23086589Townsend CK, Dillard A, Hosoda KK, Maskarinec GG, Maunakea AK, Yoshimura SR, Hughes C, Palakiko DM, Kehauoha BP, Kaholokula JK. Community-Based Participatory Research Integrates Behavioral and Biological Research to Achieve Health Equity for Native Hawaiians. Int J Environ Res Public Health. 2015 Dec 22;13(1):ijerph13010004. doi: 10.3390/ijerph13010004.
PubMed 26703660
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Partners in Care With Semi-Structured Support Group
- ClinicalTrials.gov ID
- NCT02144909
- Acronym / sponsor ID
- CHS-21514
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Diabetes self management, support group, semi structured support group
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University of HawaiiUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- Nov 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 22 May 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 investigators are conducting a feasibility study using a randomized controlled trial (RCT) design in which participants will receive the Partners in Care (PIC) diabetes self-management intervention and then be randomized to either semi-structured social support or a standard follow-up control group. Participants in the support groups will receive a culturally-tailored, semi-structured social support program delivered in a community setting by trained community peer educators and other health professionals (e.g., pharmacist). The investigators believe that the addition of a semi-structured social support component as a supplement to an evidence-based diabetes self-management intervention will improve diabetes self-care maintenance.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Partners in Care with Semi-Structured Support Group | Experimental | Behavioral: Partners in Care with Semi-Structured Support GroupPartners in Care with Semi-Structured Support Group: participants will receive the Partners in Care intervention followed by 6 semi-structured support groups, conducted every other week for 3 months. Half of the support groups will be conducted by professionals with diabetes specific knowledge, e.g., pharmacists, physicians, nutritionists. While the other half will be conducted by the trained diabetes self-management facilitator. |
| Partners in Care Standard Follow-up | No intervention | –Participants will receive the Partners in Care intervention followed by monthly healthy lifestyle tips related to diabetes self-management |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Self-reported Native Hawaiian, Filipino, or other Pacific Islander ethnic background
- Adults age >18 years of age
- English-speaking
- Physician-diagnosed type 2 diabetes
- Baseline hemoglobin A1c >8%
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 Care with Semi-Structured Support Group | Behavioural | Partners in Care with Semi-Structured Support Group |
Primary outcome
Change from Baseline hemoglobin a1c at 3 months and at 6 months
Time frame: baseline, 3 months, 6 months
Change from Baseline diabetes management functioning as measured by the Problem Areas in Diabetes questionnaire at 3 months and 6 months
Time frame: baseline, 3 months, 6 months
The PAID is a 20-item instrument that assesses the physical and social functioning of patients as well as their perceived level of mental and emotional well-being specific to living with diabetes.
3 secondary outcomes
Change from Baseline blood pressure at 3 months and 6 months
Time frame: baseline, 3 months, 6 months
Change from Baseline Total Cholesterol (including HDL and LDL) and triglycerides at 3 months and 6 months
Time frame: baseline, 3 months, 6 months
Change from Baseline weight in kg at 3 months and 6 months
Time frame: baseline, 3 months, 6 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 Jun 2015.
- Background: PubMed 23086589Sinclair KA, Makahi EK, Shea-Solatorio C, Yoshimura SR, Townsend CK, Kaholokula JK. Outcomes from a diabetes self-management intervention for Native Hawaiians and Pacific People: Partners in Care. Ann Behav Med. 2013 Feb;45(1):24-32. doi: 10.1007/s12160-012-9422-1.
- Derived from this study: PubMed 26703660Townsend CK, Dillard A, Hosoda KK, Maskarinec GG, Maunakea AK, Yoshimura SR, Hughes C, Palakiko DM, Kehauoha BP, Kaholokula JK. Community-Based Participatory Research Integrates Behavioral and Biological Research to Achieve Health Equity for Native Hawaiians. Int J Environ Res Public Health. 2015 Dec 22;13(1):ijerph13010004. doi: 10.3390/ijerph13010004.
Related trials for Diabetes Mellitus, Type 2
RecruitingObservational study
Genetics of Type 2 Diabetes in West Africans
Hypertension, Diabetes
Not yet recruitingPhase 3
A Study Comparing SHR-3167 With Insulin Degludec in Adults With Type 2 Diabetes Currently Treated With Basal Insulin
Diabetes Mellitus, Type 2
Active, not recruiting
Chrono Nutrition and Insulin Resistance in Diabetes
Diabetes Mellitus, Type 2
Not yet recruitingObservational study
Clinical Research Trial to Study Insulin Sensitivity Using Automated Glucose Clamp Technology
Obesity Type 2 Diabetes Mellitus, Obese Adults
Not yet recruitingPhase 3
A Study of Eloralintide (LY3841136) in Participants With Obesity or Overweight, Type 2 Diabetes, and Increased Cardiovascular Risk
Obesity, Overweight
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.
3 sites 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 with Semi-Structured Support Group in people with Diabetes Mellitus, Type 2, run by University of Hawaii at 3 sites 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 5 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 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Change from Baseline hemoglobin a1c at 3 months and at 6 months (time frame: baseline, 3 months, 6 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?
On the ClinicalTrials.gov record for NCT02144909, which also lists 2 linked publications.
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 Jun 2015.