Partners in Care With Semi-Structured Support Group

Diabetes Mellitus, Type 2 Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02144909
• Other study ID #: CHS-21514
• Secondary ID: U54MD007584
• Status: Completed
• Phase: N/A
• First received: November 15, 2013
• Last updated: June 1, 2015
• Start date: November 2013
• Est. completion date: September 2014

Study information

• Verified date: June 2015
• Source: University of Hawaii
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: September 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• Partners in Care with Semi-Structured Support Group

Locations

Country	Name	City	State
United States	Ke Ola Mamao	Honolulu	Hawaii
United States	Kokua Kalihi Valley	Honolulu	Hawaii
United States	Kula no na Po'e Hawai'i	Honolulu	Hawaii

Sponsors (2)

Lead Sponsor	Collaborator
University of Hawaii	National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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		baseline, 3 months, 6 months	No
Other	Change from Baseline reported amount of support as measured a questionnaire at 3 months and 6 months		baseline, 3 months, 6 months	No
Other	Change from Baseline amount of physical activity as measured a questionnaire at 3 months and 6 months		baseline, 3 months, 6 months	No
Other	Change from Baseline dietary patterns as a questionnaire at 3 months and 6 months		baseline, 3 months, 6 months	No
Primary	Change from Baseline hemoglobin a1c at 3 months and at 6 months		baseline, 3 months, 6 months	No
Primary	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.	baseline, 3 months, 6 months	No
Secondary	Change from Baseline blood pressure at 3 months and 6 months		baseline, 3 months, 6 months	No
Secondary	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	baseline, 3 months, 6 months	No
Secondary	Change from Baseline weight in kg at 3 months and 6 months		baseline, 3 months, 6 months	No