Resilient, Empowered, Active Living: REAL Diabetes Study

Diabetes Mellitus, Type 2 Clinical Trial

— REAL  

Official title:

Diabetes Self-Management Lifestyle Intervention for Urban Minority Young Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02214641
• Other study ID #: 1K01DK099202-01A1
• Secondary ID: 1K01DK099202-01A
• Status: Completed
• Phase: N/A
• Start date: October 2014
• Est. completion date: July 2017

Study information

• Verified date: October 2019
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: July 2017
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type 2

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	USC	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern California	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

References & Publications (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. — View Citation

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. — View Citation

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. — View Citation

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 R — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycated hemoglobin (HbA1C)	Measure of average blood glucose concentration over approximately the previous 12 weeks.	Baseline & 6 months.
Secondary	Audit of Diabetes-Dependent Quality of Life (ADD-QoL)	19-item survey measure assessing impact of diabetes on social, physical, and emotional functioning.	Baseline & 6 months.
Secondary	Problem Areas in Diabetes (PAID) Scale - Short Form	5-item survey measure assessing diabetes-related distress and emotional problems.	Baseline & 6 months.
Secondary	Patient Health Questionnaire-8 (PHQ-8)	8-item survey measure assessing severity of depressive symptoms (identical to PHQ-9 while omitting self-harm item).	Baseline & 6 months
Secondary	Satisfaction With Life Scale (SWLS)	5-item survey measure assessing global life satisfaction and subjective well-being.	Baseline & 6 months.
Secondary	Summary of Diabetes Self-Care Activities (SDSCA)	14 items assessing diet, physical activity, medication adherence and other self-care behaviors relevant to diabetes.	Baseline & 6 months