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Resilient, Empowered, Active Living: REAL Diabetes Study (REAL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02214641
Recruitment Status : Completed
First Posted : August 12, 2014
Last Update Posted : October 7, 2019
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Beth Pyatak, University of Southern California

Brief Summary:

This three-year award will pilot-test an innovative intervention, Resilient, Empowered, Active Living with Diabetes (REAL), targeting underserved minority young adults with poorly-controlled diabetes. The individually tailored, community-based intervention merges findings of an in-depth needs assessment, principles of an evidence-based occupational therapy intervention (Lifestyle Redesign®) and evidence-based diabetes self-management strategies. A proof-of-concept study demonstrated that REAL is feasible to implement, acceptable to young adults with type 1 diabetes and type 2 diabetes, and has potential to produce positive changes in diabetes self-care and glycemic control. The study will randomize 80 young adults with diabetes to receive either the six-month REAL intervention or an attention control condition. Blinded data collectors will assess glycemic control, diabetes self-care behaviors and quality of life outcomes, as well as potential intervention mediators, before and after the six-month intervention. It is anticipated that findings from this pilot study will be used to inform a large-scale randomized controlled trial of the REAL intervention.

The study's specific aims and hypotheses are as follows:

Aim 1. Determine the intervention's efficacy for the primary outcomes: glycemic control and diabetes self-care.

Hypothesis: At 6 months (immediately following the intervention), intervention group participants will demonstrate improvements in A1C and diabetes self-care as compared to control group participants.

Aim 2. Conduct exploratory analyses of the intervention's impact on secondary outcomes and potential mediating mechanisms (to inform power estimates for a large-scale RCT).

Hypothesis 1: At 6 months, intervention group participants will demonstrate improvements in secondary outcomes: diabetes-related stress and quality of life, depression, and life satisfaction as compared to control group participants.

Hypothesis 2: At 6 months, intervention group participants will demonstrate improvements in potential mediators of the intervention: habit strength, problem solving, activity participation, self-efficacy and diabetes knowledge as compared to baseline.

Aim 3. Conduct a process evaluation utilizing mixed methods to evaluate and refine intervention delivery (e.g. treatment fidelity, patient satisfaction) and study procedures (e.g. recruitment, retention, testing protocol).


Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Behavioral: Resilient, Empowered, Active Living with Diabetes Behavioral: Information Control Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 81 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Diabetes Self-Management Lifestyle Intervention for Urban Minority Young Adults
Study Start Date : October 2014
Actual Primary Completion Date : June 2016
Actual Study Completion Date : July 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Lifestyle intervention
Resilient, Empowered, Active Living (REAL) Diabetes
Behavioral: Resilient, Empowered, Active Living with Diabetes
Individualized lifestyle intervention incorporating the following topics: Diabetes knowledge; access to healthcare; communication with healthcare providers; incorporation of diabetes self-care tasks within daily habits and routines; social support; and emotional well-being. Participants receive a total of 10-16 hours of intervention by a licensed occupational therapist with training in diabetes education, motivational interviewing and the REAL Diabetes intervention protocol.

Active Comparator: Information Control
Participants will receive a packet of informational materials about diabetes, and receive periodic follow-up phone calls to match for attention dose.
Behavioral: Information Control
Participants will receive a packet of informational materials about diabetes, and receive periodic follow-up phone calls to match for attention dose. The packet of materials will be delivered in an initial home visit. Follow-up phone calls will occur at approximately two week intervals to inquire whether participants have reviewed specific sections of the intervention materials, and clarify information included in the packet.




Primary Outcome Measures :
  1. Glycated hemoglobin (HbA1C) [ Time Frame: Baseline & 6 months. ]
    Measure of average blood glucose concentration over approximately the previous 12 weeks.


Secondary Outcome Measures :
  1. Audit of Diabetes-Dependent Quality of Life (ADD-QoL) [ Time Frame: Baseline & 6 months. ]
    19-item survey measure assessing impact of diabetes on social, physical, and emotional functioning.

  2. Problem Areas in Diabetes (PAID) Scale - Short Form [ Time Frame: Baseline & 6 months. ]
    5-item survey measure assessing diabetes-related distress and emotional problems.

  3. Patient Health Questionnaire-8 (PHQ-8) [ Time Frame: Baseline & 6 months ]
    8-item survey measure assessing severity of depressive symptoms (identical to PHQ-9 while omitting self-harm item).

  4. Satisfaction With Life Scale (SWLS) [ Time Frame: Baseline & 6 months. ]
    5-item survey measure assessing global life satisfaction and subjective well-being.

  5. Summary of Diabetes Self-Care Activities (SDSCA) [ Time Frame: Baseline & 6 months ]
    14 items assessing diet, physical activity, medication adherence and other self-care behaviors relevant to diabetes.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed with type 1 or type 2 diabetes mellitus for a minimum of 12 months
  • Most recent A1C ≥8.0%
  • Fluent in English or Spanish
  • Reachable by telephone or text message
  • Willing to participate in study activities
  • Reside in Los Angeles County with no plans to relocate

Exclusion Criteria:

  • Pregnant or planning to become pregnant
  • Cognitive impairment or severe disability limiting life expectancy
  • Participated in lifestyle intervention targeting diabetes within past 12 months
  • Participated in formative research related to intervention development.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02214641


Locations
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United States, California
USC
Los Angeles, California, United States, 90089
Sponsors and Collaborators
University of Southern California
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Elizabeth Pyatak, PhD, OTR/L University of Southern California

Publications of Results:
Other Publications:

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Responsible Party: Beth Pyatak, Associate Professor, University of Southern California
ClinicalTrials.gov Identifier: NCT02214641    
Other Study ID Numbers: 1K01DK099202-01A1 ( U.S. NIH Grant/Contract )
1K01DK099202-01A1 ( U.S. NIH Grant/Contract )
First Posted: August 12, 2014    Key Record Dates
Last Update Posted: October 7, 2019
Last Verified: October 2019
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases