Clinical trial NCT02144909: Partners in Care With Semi-Structured Support Group
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Diabetes self management
support group
semi structured support group
Lead sponsor: University of Hawaii
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2014-05-22
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Change from Baseline hemoglobin a1c at 3 months and at 6 months
timeFrame: baseline, 3 months, 6 months
measure: Change from Baseline diabetes management functioning as measured by the Problem Areas in Diabetes questionnaire at 3 months and 6 months
timeFrame: baseline, 3 months, 6 months
Secondary outcomes:
measure: Change from Baseline blood pressure at 3 months and 6 months
timeFrame: baseline, 3 months, 6 months
measure: Change from Baseline Total Cholesterol (including HDL and LDL) and triglycerides at 3 months and 6 months
timeFrame: baseline, 3 months, 6 months
measure: Change from Baseline weight in kg at 3 months and 6 months
timeFrame: baseline, 3 months, 6 months
Other outcomes:
measure: 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
timeFrame: baseline, 3 months, 6 months
measure: Change from Baseline reported amount of support as measured a questionnaire at 3 months and 6 months
timeFrame: baseline, 3 months, 6 months
measure: Change from Baseline amount of physical activity as measured a questionnaire at 3 months and 6 months
timeFrame: baseline, 3 months, 6 months
measure: Change from Baseline dietary patterns as a questionnaire at 3 months and 6 months
timeFrame: baseline, 3 months, 6 months
Locations:
city: Honolulu
country: United States
facility: Kula no na Po'e Hawai'i
state: Hawaii
city: Honolulu
country: United States
facility: Ke Ola Mamao
state: Hawaii
city: Honolulu
country: United States
facility: Kokua Kalihi Valley
state: Hawaii
Study officials:
References:
citation: 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.
citation: 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.