Partners in Care With Semi-Structured Support Group

NCT02144909 | Completed

• 2 other identifiers: CHS-21514U54MD007584
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 3

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

Keywords

Diabetes self management; support group; semi structured support group

Outcome Measures

Primary Outcomes (2)

• Change from Baseline hemoglobin a1c at 3 months and at 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

  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 Outcomes (3)

• Change from Baseline blood pressure at 3 months and 6 months

  baseline, 3 months, 6 months

• Change from Baseline Total Cholesterol (including HDL and LDL) and triglycerides at 3 months and 6 months

  baseline, 3 months, 6 months

• Change from Baseline weight in kg at 3 months and 6 months

  baseline, 3 months, 6 months

Other Outcomes (4)

• 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

• Change from Baseline reported amount of support as measured a questionnaire at 3 months and 6 months

  baseline, 3 months, 6 months

• Change from Baseline amount of physical activity as measured a questionnaire at 3 months and 6 months

  baseline, 3 months, 6 months

Study Arms (2)

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.

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

Interventions

Partners in Care with Semi-Structured Support Group BEHAVIORAL

Partners in Care with Semi-Structured Support Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Hawaii: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (3)

Kula no na Po'e Hawai'i

Honolulu, Hawaii, 96813, United States

Location

Ke Ola Mamao

Honolulu, Hawaii, 96817, United States

Location

Kokua Kalihi Valley

Honolulu, Hawaii, 96819, United States

Location

Related Publications (2)

• 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.

  PMID: 23086589 BACKGROUND

• 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.

  PMID: 26703660 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Research Specialist

Study Record Dates

• First Submitted: November 15, 2013
• First Posted: May 22, 2014
• Study Start: November 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: September 1, 2014
• Last Updated: June 3, 2015

Record last verified: 2015-06

Locations

US (3)