Resilient, Empowered, Active Living: REAL Diabetes Study
NCT ID: NCT02214641
Last Updated: 2019-10-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
81 participants
INTERVENTIONAL
2014-10-31
2017-07-31
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Lifestyle intervention
Resilient, Empowered, Active Living (REAL) Diabetes
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.
Information Control
Participants will receive a packet of informational materials about diabetes, and receive periodic follow-up phone calls to match for attention dose.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
30 Years
ALL
No
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
University of Southern California
OTHER
Responsible Party
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Beth Pyatak
Associate Professor
Principal Investigators
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Elizabeth Pyatak, PhD, OTR/L
Role: PRINCIPAL_INVESTIGATOR
University of Southern California
Locations
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USC
Los Angeles, California, United States
Countries
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References
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Pyatak EA, Florindez D, Peters AL, Weigensberg MJ. "We are all gonna get diabetic these days": the impact of a living legacy of type 2 diabetes on Hispanic young adults' diabetes care. Diabetes Educ. 2014 Sep-Oct;40(5):648-58. doi: 10.1177/0145721714535994. Epub 2014 May 27.
Pyatak EA, Sequeira PA, Whittemore R, Vigen CP, Peters AL, Weigensberg MJ. Challenges contributing to disrupted transition from paediatric to adult diabetes care in young adults with type 1 diabetes. Diabet Med. 2014 Dec;31(12):1615-24. doi: 10.1111/dme.12485. Epub 2014 May 26.
Pyatak EA, Florindez D, Weigensberg MJ. Adherence decision making in the everyday lives of emerging adults with type 1 diabetes. Patient Prefer Adherence. 2013 Jul 29;7:709-18. doi: 10.2147/PPA.S47577. Print 2013.
Pyatak EA, Carandang K, Davis S. Developing a Manualized Occupational Therapy Diabetes Management Intervention: Resilient, Empowered, Active Living With Diabetes. OTJR (Thorofare N J). 2015 Jul;35(3):187-94. doi: 10.1177/1539449215584310.
Pyatak EA, Carandang K, Vigen C, Blanchard J, Sequeira PA, Wood JR, Spruijt-Metz D, Whittemore R, Peters AL. Resilient, Empowered, Active Living with Diabetes (REAL Diabetes) study: Methodology and baseline characteristics of a randomized controlled trial evaluating an occupation-based diabetes management intervention for young adults. Contemp Clin Trials. 2017 Mar;54:8-17. doi: 10.1016/j.cct.2016.12.025. Epub 2017 Jan 5.
Vigen CLP, Carandang K, Blanchard J, Sequeira PA, Wood JR, Spruijt-Metz D, Whittemore R, Peters AL, Pyatak EA. Psychosocial and Behavioral Correlates of A1C and Quality of Life Among Young Adults With Diabetes. Diabetes Educ. 2018 Dec;44(6):489-500. doi: 10.1177/0145721718804170. Epub 2018 Oct 8.
Carandang KM, Pyatak EA. Feasibility of a Manualized Occupation-Based Diabetes Management Intervention. Am J Occup Ther. 2018 Mar/Apr;72(2):7202345040p1-7202345040p6. doi: 10.5014/ajot.2018.021790.
Pyatak EA, Carandang K, Vigen CLP, Blanchard J, Diaz J, Concha-Chavez A, Sequeira PA, Wood JR, Whittemore R, Spruijt-Metz D, Peters AL. Occupational Therapy Intervention Improves Glycemic Control and Quality of Life Among Young Adults With Diabetes: the Resilient, Empowered, Active Living with Diabetes (REAL Diabetes) Randomized Controlled Trial. Diabetes Care. 2018 Apr;41(4):696-704. doi: 10.2337/dc17-1634. Epub 2018 Jan 19.
Salvy SJ, Carandang K, Vigen CL, Concha-Chavez A, Sequeira PA, Blanchard J, Diaz J, Raymond J, Pyatak EA. Effectiveness of social media (Facebook), targeted mailing, and in-person solicitation for the recruitment of young adult in a diabetes self-management clinical trial. Clin Trials. 2020 Dec;17(6):664-674. doi: 10.1177/1740774520933362. Epub 2020 Jul 6.
Other Identifiers
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