Resilient, Empowered, Active Living: REAL Diabetes Study
Study Details
Study Description
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 |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| 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.
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| 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.
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Outcome Measures
Primary Outcome Measures
- Glycated hemoglobin (HbA1C) [Baseline & 6 months.]
Measure of average blood glucose concentration over approximately the previous 12 weeks.
Secondary Outcome Measures
- Audit of Diabetes-Dependent Quality of Life (ADD-QoL) [Baseline & 6 months.]
19-item survey measure assessing impact of diabetes on social, physical, and emotional functioning.
- Problem Areas in Diabetes (PAID) Scale - Short Form [Baseline & 6 months.]
5-item survey measure assessing diabetes-related distress and emotional problems.
- Patient Health Questionnaire-8 (PHQ-8) [Baseline & 6 months]
8-item survey measure assessing severity of depressive symptoms (identical to PHQ-9 while omitting self-harm item).
- Satisfaction With Life Scale (SWLS) [Baseline & 6 months.]
5-item survey measure assessing global life satisfaction and subjective well-being.
- Summary of Diabetes Self-Care Activities (SDSCA) [Baseline & 6 months]
14 items assessing diet, physical activity, medication adherence and other self-care behaviors relevant to diabetes.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Diagnosed with type 1 or type 2 diabetes mellitus for a minimum of 12 months
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Most recent A1C ≥8.0%
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Fluent in English or Spanish
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Reachable by telephone or text message
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Willing to participate in study activities
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Reside in Los Angeles County with no plans to relocate
Exclusion Criteria:
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Pregnant or planning to become pregnant
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Cognitive impairment or severe disability limiting life expectancy
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Participated in lifestyle intervention targeting diabetes within past 12 months
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Participated in formative research related to intervention development.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 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
- Principal Investigator: Elizabeth Pyatak, PhD, OTR/L, University of Southern California
Study Documents (Full-Text)
None provided.More Information
Publications
- 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, 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.
- 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.
- 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, 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, 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.
- 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.
- 1K01DK099202-01A1
- 1K01DK099202-01A1