Partners in Care With Semi-Structured Support Group

NCT ID: NCT02144909

Last Updated: 2015-06-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2014-09-30

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.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Partners in Care with Semi-Structured Support Group

Intervention Type: BEHAVIORAL

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Partners in Care with Semi-Structured Support Group

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role: collaborator

University of Hawaii

OTHER

Sponsor Role: lead

Responsible Party

Claire Townsend

Clinical Research Specialist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Kula no na Po'e Hawai'i

Honolulu, Hawaii, United States

Ke Ola Mamao

Honolulu, Hawaii, United States

Kokua Kalihi Valley

Honolulu, Hawaii, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 23086589 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26703660 (View on PubMed)

Other Identifiers

U54MD007584

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CHS-21514

Identifier Type: -

Identifier Source: org_study_id