Resilient, Empowered, Active Living: REAL Diabetes Study

NCT02214641 | Completed DMC

• 1 other identifier: 1K01DK099202-01A1
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

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).

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Glycated hemoglobin (HbA1C)

  Measure of average blood glucose concentration over approximately the previous 12 weeks.

  Baseline & 6 months.

Secondary Outcomes (5)

• Audit of Diabetes-Dependent Quality of Life (ADD-QoL)

  Baseline & 6 months.

• Problem Areas in Diabetes (PAID) Scale - Short Form

  Baseline & 6 months.

• Patient Health Questionnaire-8 (PHQ-8)

  Baseline & 6 months

• Satisfaction With Life Scale (SWLS)

  Baseline & 6 months.

• Summary of Diabetes Self-Care Activities (SDSCA)

  Baseline & 6 months

Study Arms (2)

Lifestyle intervention

EXPERIMENTAL

Resilient, Empowered, Active Living (REAL) Diabetes

Behavioral: Resilient, Empowered, Active Living with Diabetes

Information Control

ACTIVE COMPARATOR

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

Interventions

Resilient, Empowered, Active Living with Diabetes BEHAVIORAL

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.

Lifestyle intervention

Information Control BEHAVIORAL

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.

Information Control

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Southern California: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

USC

Los Angeles, California, 90089, United States

Location

Related Publications (9)

• 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.

  PMID: 24867918 BACKGROUND

• 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.

  PMID: 24798586 BACKGROUND

• 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.

  PMID: 23935361 BACKGROUND

• 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.

  PMID: 26594741 BACKGROUND

• 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.

  PMID: 28064028 BACKGROUND

• 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.

  PMID: 30295170 BACKGROUND

• 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.

  PMID: 29426394 BACKGROUND

• 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.

  PMID: 29351961 RESULT

• 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.

  PMID: 32627589 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

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

Study Officials

• Elizabeth Pyatak, PhD, OTR/L

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 8, 2014
• First Posted: August 12, 2014
• Study Start: October 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: July 1, 2017
• Last Updated: October 7, 2019

Record last verified: 2019-10

Locations

US (1)