Evaluation of an Intervention for Young Adults With Diabetes: Resilient, Empowered, Active Living-Telehealth (REAL-T) (REAL-T)
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|ClinicalTrials.gov Identifier: NCT04023487|
Recruitment Status : Recruiting
First Posted : July 17, 2019
Last Update Posted : October 4, 2019
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 1||Behavioral: Resilient, Empowered, Active Living-Telehealth (REAL-T)||Not Applicable|
Evaluation of a Complex Behavioral Intervention for Young Adults with Diabetes: The Resilient, Empowered, Active Living-Telehealth (REAL-T) Study will address the unmet self-management and psychosocial needs of young adults (YAs) with type 1 diabetes (T1D).
We will conduct a large-scale randomized controlled trial (n=210) to compare the 6-month REAL-T intervention to usual care in improving glycemic control (A1c and continuous glucose monitor-derived measures), psychosocial well-being, and hypothesized intervention mediators. In addition, we will perform health economic analyses to determine the extent to which REAL-T is cost-effective or produces cost savings.
The study's specific aims are as follows:
Aim 1: Evaluate the efficacy of REAL-T in improving glycemic control and psychosocial well-being.
- Hypothesis 1: Over a 6-month intervention period (including 3 and 6 month measures), YAs with T1D who receive REAL-T demonstrate improvements in glycemic control, in comparison to YAs with T1D who receive usual care.
- Hypothesis 2: Over a 6-month period (including 3 and 6 month measures), YAs with T1D who receive REAL-T demonstrate gains in psychosocial well-being in comparison to YAs with T1D who receive usual care.
Aim 2: Assess the post-intervention durability (at 3 and 6 months post-intervention) of REAL-T's effects on glycemic control and psychosocial well-being.
- Hypothesis 1: Among YAs with T1D, improvements in glycemic control that result from REAL-T relative to usual care are maintained at 3 and 6 months post-treatment.
- Hypothesis 2: Among YAs with T1D, improvements in psychosocial well-being that result from REAL-T relative to usual care are maintained at 3 and 6 months post-treatment.
Aim 3: Examine mediating mechanisms of the REAL-T intervention's effects on glycemic control and psychosocial well-being through structural equation modeling (SEM).
- Hypothesis 1: Improvements in diabetes self-care behaviors mediate positive intervention effects on glycemic control and psychosocial well-being.
- Hypothesis 2: Improvements in self-efficacy mediate positive intervention effects on psychosocial well-being and partially mediate positive effects on diabetes self-care behaviors.
- Hypothesis 3: Improvements in habit strength for diabetes self-care behaviors partially mediate positive intervention effects on the performance of diabetes self-care behaviors.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||210 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Evaluation of a Complex Intervention for Young Adults With Diabetes: The Resilient, Empowered, Active Living-Telehealth (REAL-T) Study|
|Actual Study Start Date :||October 1, 2019|
|Estimated Primary Completion Date :||June 2022|
|Estimated Study Completion Date :||December 2022|
Experimental: Lifestyle Intervention
Resilient, Empowered, Active Living-Telehealth (REAL-T)
Behavioral: Resilient, Empowered, Active Living-Telehealth (REAL-T)
REAL-T is an individually-tailored occupational therapy intervention that focuses on incorporating diabetes self-care into participants' daily habits and routines. Participants receive approximately 12 hours of intervention, delivered via telehealth over 6 months by a licensed occupational therapist with training in diabetes education, motivational interviewing, and the REAL Diabetes intervention protocol.
No Intervention: Usual Care
Participants will continue to have access to routine diabetes care from the provider of their choosing; they will not receive any study-related intervention.
- Change in glycemic control, using Glycated Hemoglobin (HbA1C) [ Time Frame: Baseline, 3 months, 6 months, 9 months, and 12 months ]HbA1C is a measure of average blood glucose concentration over approximately the previous 12 weeks. HbA1C will be measured using a finger-prick test and DCA Vantage Analyzer point-of-care system.
- Change in diabetes-related quality of life, using the "Audit of Diabetes-Dependent Quality of Life-15" (ADD-QoL-15) [ Time Frame: Baseline, 6 months, and 12 months ]15-item questionnaire assessing diabetes-related quality of life (qol). Each item contains two parts. Part A is: "If I did not have diabetes, [the question topic] would be", followed by 5 options ranging from "very much better" (or similar; scored as -3) to "worse" (or similar; scored as 1). The fourth option is always "the same" and scored as 0. Part B is: "[the question topic] is" followed by 4 options ranging from "very important" (scored as 3) to "not at all important" (scored as 0). For each question, scores on parts A and B are multiplied, and the 15 products are summed for a total score. Questions 2, 4, 6, 8, 9, & 11 have preliminary yes/no questions, and when a "no" response is given, parts A and B are skipped and the score for that question is 0. The minimum score on each question is -9 and the maximum is 3, with total scores ranging from -135 to 45. Positive scores reflect perceived positive impact of diabetes on qol; negative scores reflect perceived negative impact on qol.
- Change in diabetes-related emotional distress, using the "Diabetes Distress Scale" (DDS) [ Time Frame: Baseline, 6 months, and 12 months ]17-item questionnaire assessing diabetes-related emotional distress. Total scores (mean score on all 17 items) range from 1 to 6. Sub-scale scores (emotional burden, physician-related distress, regimen-related distress, and interpersonal distress) each range from 1 to 6. A total or sub-scale score 2.0 - 2.9 should be considered 'moderate distress,' and a total or sub-scale score > 3.0 should be considered 'high distress.'
- Change in functional health and well-being, using the "SF-12v2® Health Survey" [ Time Frame: Baseline, 6 months, and 12 months ]Short Form 12-item Health Survey Ver. 2 (SF-12v2) is a 12-item questionnaire assessing functional health & well-being over the last 4 weeks in 8 health domains (physical functioning, role participation with physical health problems, bodily pain, general health, vitality, social functioning, role participation with emotional health problems, mental health), all from the patient's point of view. These 8 domains can be summarized into a physical component summary (PCS) and a mental component summary (MCS). Higher scores indicate a better health state. MCS and PCS scores range from 0-100. Scores are calibrated using general population-derived normative data so that 50 is the avg score or norm. Results can be further summarized into a single preference-based health utility number ranging from 1 (equivalent to perfect health) to 0 (equivalent to being dead), using a complex scoring algorithm (SF-6D) derived from surveying a general U.S. population's preferences for specific health states.
- Change in global diabetes self-management, using the "Diabetes Self-Management Questionnaire-Revised" (DSMQ-R). [ Time Frame: Baseline, 3 months, 6 months, 9 months, and 12 months ]27-item questionnaire assessing self-care activities associated with glycemic control. Higher values indicate more effective self-management. Transformed scores = Actual sum of items / maximum possible sum of items x 10. Total transformed scores range from 0 to 10. Transformed scores on six sub-scales (Dietary control, Glucose management, Glucose monitoring, Medication adherence, Physical activity, and Physician contact) also range from 0 to 10.
- Change in medication adherence, using the "3-item adherence self-report scale" questionnaire [ Time Frame: Baseline, 3 months, 6 months, 9 months, and 12 months ]3-item questionnaire (Wilson,Lee, Fowler, & Rogers, 2016) assessing adherence to diabetes medication regimen. Item responses for the three adherence items are linearly transformed to a 0-100 scale with zero being the worst adherence, and 100 the best. A total summary score is calculated as the mean of the three individual items, with a range of 0 to 100.
- Change in automaticity of behavior (testing blood sugar), using the "Self-Report Behavioural Automaticity Index" (SRBAI) [ Time Frame: Baseline, 3 months, 6 months, 9 months, and 12 months ]4-item questionnaire assessing habit strength for testing blood sugar, using 7-point likert scales. Scores range from 4 to 28. A higher score indicates greater automaticity.
- Change in self-efficacy for performing diabetes self-management, using the "Diabetes Empowerment Scale - Short Form" (DES-SF) [ Time Frame: Baseline, 3 months, 6 months, 9 months, and 12 months ]8-item questionnaire assessing self-efficacy for performing diabetes self-management, using 5-point likert scales. The scale is scored by averaging the scores of all completed items. Scores range from 8 to 40, with higher scores indicating higher self-efficacy.
- Change in autonomy of taking insulin and/or checking blood sugar, using the "Treatment Self-Regulation Questionnaire" (TSRQ) [ Time Frame: Baseline, 3 months, 6 months, 9 months, and 12 months ]19-item questionnaire, adapted for type 1 diabetes, assessing the degree to which a person's motivation for a particular behavior or a set of behaviors is relatively autonomous or self-determined. Each item can receive a value ranging from 1 - 7 as selected by the participant. The scale has 2 sub-scales: the autonomous regulatory style and the controlled regulatory style. Calculating the scores for the sub-scales consists of averaging the items on that sub-scale. A Relative Autonomous Motivation Index can be formed by subtracting the average for the controlled reasons from the average for the autonomous reasons. Scores range from 1 to 7, with 7 indicating a strong identification with the given autonomy style. The autonomous regulatory style represents the most self-determined form of motivation.
- Change in cost to patients [ Time Frame: Baseline, 3 months, 6 months, 9 months, and 12 months ]9 diabetes-related expense questions designed by the study (polar questions, multiple choice, and open-ended). Questions assess loss of income or other productivity due to diabetes (3 items), and impact of cost and health insurance on access to and use of insulin and test strips (6 items).
- Change in self management of blood glucose, using the # of blood glucose checks [ Time Frame: Baseline, 3 months, 6 months, 9 months, and 12 months ]The number of blood glucose checks over the 14 days prior to each assessment session will be recorded through download of participants' meter data or, if incompatible, through manual review of blood glucose checks recorded on the participant's meter.
- Change in glycemic control, using Percent Time-in-Range [ Time Frame: Baseline, 6 months, and 12 months ]The proportion of time when blood glucose was between 70 and 180 mg/dl, as measured by an Abbott FreeStyle Libre Pro continuous glucose monitor worn on the arm for 14 days.
- Change in glycemic control, using Percent Time in Hyperglycemia [ Time Frame: Baseline, 6 months, and 12 months ]The proportion of time when blood glucose was above 180 mg/dl, as measured by an Abbott FreeStyle Libre Pro continuous glucose monitor worn on the arm for 14 days.
- Change in glycemic control, using Percent Time in Hypoglycemia [ Time Frame: Baseline, 6 months, and 12 months ]The proportion of time when blood glucose was below 70 mg/dl, as measured by an Abbott FreeStyle Libre Pro continuous glucose monitor worn on the arm for 14 days.
- Telehealth Satisfaction [ Time Frame: 6 months ]18-item questionnaire assessing intervention participants' satisfaction with the study's telehealth procedures. Scores on items 4-14 (likert-scaled items) range from 1 to 5, with 5 indicating higher satisfaction. Total score is calculated by averaging items 4-14. The remaining 7 items are Yes/No, Yes/No/Maybe, and open-ended items used to characterize the population descriptively and indicate willingness to use/recommend telehealth in the future. These additional 7 items are not used in any scoring calculations.
- Change in cost to payor [ Time Frame: Baseline, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 7 months, 8 months, 9 months, 10 months, 11 months, and 12 months ]8-item healthcare utilization questionnaire designed by the study. Polar; Yes/No questions about health service usage in the last month: (e.g., "have you had to be admitted to the hospital?"). Open-ended questions about number of time health services were used, (e.g., "how many times were you admitted to the hospital for reasons related to diabetes?").
- Background Information [ Time Frame: Baseline ]19-item questionnaire, designed by the study, gathering background data on demographic characteristics and baseline healthcare utilization (for prior 3 months). No total score will be calculated. Scores on individual items will be used as covariates in various analyses.
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): NCT04023487
|Contact: Elizabeth Pyatak, PhD, OTR/Lfirstname.lastname@example.org|
|Contact: Jeanine Blanchard, PhD, OTR/Lemail@example.com|
|United States, California|
|USC Center for Health Professionals||Recruiting|
|Los Angeles, California, United States, 90033|
|Contact: Elizabeth A Pyatak, PhD 323-442-2615 firstname.lastname@example.org|
|Principal Investigator:||Elizabeth Pyatak, PhD, OTR/L||University of Southern California|