- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02144909
Partners in Care With Semi-Structured Support Group
June 1, 2015 updated by: Claire Townsend, University of Hawaii
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
65
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Hawaii
-
Honolulu, Hawaii, United States, 96813
- Kula no na Po'e Hawai'i
-
Honolulu, Hawaii, United States, 96817
- Ke Ola Mamao
-
Honolulu, Hawaii, United States, 96819
- Kokua Kalihi Valley
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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%
Exclusion Criteria:
- 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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Partners in Care with Semi-Structured Support Group
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.
|
|
No Intervention: Partners in Care Standard Follow-up
Participants will receive the Partners in Care intervention followed by monthly healthy lifestyle tips related to diabetes self-management
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline hemoglobin a1c at 3 months and at 6 months
Time Frame: baseline, 3 months, 6 months
|
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.
|
baseline, 3 months, 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline blood pressure at 3 months and 6 months
Time Frame: baseline, 3 months, 6 months
|
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
|
Total Cholesterol (including HDL and LDL) and triglycerides will be measured with the Cholestech LDX analyzer
|
baseline, 3 months, 6 months
|
Change from Baseline weight in kg at 3 months and 6 months
Time Frame: baseline, 3 months, 6 months
|
baseline, 3 months, 6 months
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from Baseline reported diabetes self-care activities as measured by the Summary of Diabetes Self-Care Activities questionnaire at 3 months and 6 months
Time Frame: baseline, 3 months, 6 months
|
baseline, 3 months, 6 months
|
Change from Baseline reported amount of support as measured a questionnaire at 3 months and 6 months
Time Frame: baseline, 3 months, 6 months
|
baseline, 3 months, 6 months
|
Change from Baseline amount of physical activity as measured a questionnaire at 3 months and 6 months
Time Frame: baseline, 3 months, 6 months
|
baseline, 3 months, 6 months
|
Change from Baseline dietary patterns as a questionnaire at 3 months and 6 months
Time Frame: baseline, 3 months, 6 months
|
baseline, 3 months, 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Townsend 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2013
Primary Completion (Actual)
July 1, 2014
Study Completion (Actual)
September 1, 2014
Study Registration Dates
First Submitted
November 15, 2013
First Submitted That Met QC Criteria
May 21, 2014
First Posted (Estimate)
May 22, 2014
Study Record Updates
Last Update Posted (Estimate)
June 3, 2015
Last Update Submitted That Met QC Criteria
June 1, 2015
Last Verified
June 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHS-21514
- U54MD007584 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Diabetes Mellitus, Type 2
-
SanofiCompletedType 1 Diabetes Mellitus-Type 2 Diabetes MellitusHungary, Russian Federation, Germany, Poland, Japan, United States, Finland
-
Griffin HospitalCalifornia Walnut CommissionCompletedDIABETES MELLITUS TYPE 2United States
-
Scripps Whittier Diabetes InstituteSan Diego State UniversityCompletedType 2 Diabetes Mellitus (T2DM)United States
-
Mannkind CorporationTerminatedType 2 Diabetes Mellitus | Type 1 Diabetes MellitusUnited States
-
US Department of Veterans AffairsAmerican Diabetes AssociationCompletedType 2 Diabetes MellitusUnited States
-
Dexa Medica GroupCompletedType-2 Diabetes MellitusIndonesia
-
AstraZenecaNot yet recruiting
-
Daewoong Pharmaceutical Co. LTD.Not yet recruitingT2DM (Type 2 Diabetes Mellitus)
-
Zhongda HospitalRecruitingType 2 Diabetes Mellitus (T2DM)China
-
Shanghai Golden Leaf MedTec Co. LtdRecruitingType 2 Diabetes Mellitus (T2DM)China
Clinical Trials on Partners in Care with Semi-Structured Support Group
-
Centre Hospitalier Universitaire de Saint EtienneL'École Nationale des Solidarités, de l'Encadrement et de l'Intervention...RecruitingPsychiatric HospitalizationFrance
-
Maastricht University Medical CenterActive, not recruitingSquamous Cell Carcinoma of the Head and Neck | Squamous Cell Carcinoma of Head and Neck | Skin Cancer | Patient Satisfaction | Decision Making | Squamous Cell Carcinoma | Cutaneous Squamous Cell Carcinoma of the Head and Neck | Cutaneous Squamous Cell Carcinoma | High-Risk Cancer | Preference, Patient | I...Netherlands
-
UNC Lineberger Comprehensive Cancer CenterFogarty International Center of the National Institute of HealthCompletedCervical CancerSouth Africa
-
Ataturk UniversityActive, not recruitingNursing Care for Gastrointestinal Cancer PatientsTurkey
-
University of Texas at AustinUnknownSepsis | Shock | Critical Illness | Shock, Septic | Respiratory Failure | Chronic Disease | Respiratory Distress Syndrome, Adult | Shock, HypovolemicUnited States
-
Centre Francois BaclesseLigue contre le cancer, FranceRecruitingLong Term Cancer Side Effects | Supportive Care in Cancer | Cancer Survivorship Care Plan | Advanced Nurse Practitioner | Pelvic Gynecological CancerFrance
-
Case Comprehensive Cancer CenterCompletedHead and Neck CancerUnited States
-
University of Massachusetts, WorcesterCenters for Disease Control and PreventionCompleted
-
University Hospital, BordeauxCompleted
-
Prof. Dr. Michael ChristRoche Pharma AG; Jena University Hospital; City Hospital Fürth; Bayrisches Rotes... and other collaboratorsTerminated