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Completed

NCT Number: NCT03652389

i-Matter: Investigating an mHealth Texting Tool for Embedding Patient-reported Data Into Diabetes Management

This study will integrate a technology-based patient-reported outcome (PRO) system [herein MJS DIABETES] that incorporates patients' perspective of their disease and functional status into the management of type 2 diabetes (T2D) in primary care practices. MJS DIABETES is an innovative mobile platform that utilizes text-messaging to capture patients' self-reported PROs in real-time; enhance patient engagement through data-driven feedback and motivational messages; and create dynamic visualizations of the PROs that can be shared in printed reports, and integrated into the EHR; thus making it actionable for patients and their PCPs.

Using a mixed-methods design, this study will be conducted in 2 phases: 1) a formative phase, using the evidence-based user-centered design approach; and 2) a clinical-efficacy phase. For the formative phase, a qualitative research method will be used to: a) adapt MJS to the needs of PCPs and T2D patients; b) integrate MJS DIABETES into the EHR system, the primary care practice and the lives of patients with T2D; and c) evaluate the usability of MJS DIABETES in a subset of T2D patients and their PCPs in order to optimize the tool's performance and workflow integration.

For the clinical efficacy phase, a randomized control trial will be used to identify the efficacy of MJS DIABETES versus Usual Care (UC) on reduction HbA1c at 12-months, among 282 patients with T2D who receive care in safety-net practices.

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Key information

Conditions

Type2 Diabetes

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York University School of Medicine

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Primary Care Provider Inclusion Criteria:

  • Fulltime primary care provider (MD/DO, NP) practicing at the participating family health centers (FHCs) and,
  • Provide care to at least five patients with a diagnosis of T2D.

Patient Inclusion Criteria:

  • Have a diagnosis of T2D for ≥6 months;
  • Have uncontrolled T2D defined as HbA1c >7% documented in the EHR on at least two visits in the past year;
  • Fluency in English or Spanish;
  • Be willing to send/receive text messages; and

Exclusion criteria

  • Have a diagnosis of T2D for ≥6 months;
  • Have uncontrolled T2D defined as HbA1c >7% documented in the EHR on at least two visits in the past year;
  • Fluency in English or Spanish;
  • Be willing to send/receive text messages; and

Treatment and study plan

MJS Diabetes

Behavioral

patients will receive and respond to daily PRO (patient recorded outcomes) via text messages and report SMBG (self monitoring blood glucose), if insulin dependent, over the course of a 12 month period. They will also receive feedback and motivational messages based on patterns of their PROs

Primary outcomes

  1. HbA1c Level at Baseline

    Time frame: Baseline

    Hemoglobin A1c (HbA1c) extracted from patient medical record. Reported means and 95% confidence intervals are model-adjusted and utilized multiple imputation.

  2. HbA1c Level at Month 12

    Time frame: Month 12

    Hemoglobin A1c (HbA1c) extracted from patient medical record. Reported means and 95% confidence intervals are model-adjusted and utilized multiple imputation.

Secondary outcomes

  1. Summary of Diabetes Self-Care Activities (SDSCA): Diet Subscale Score

    Time frame: Baseline

    The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing, and foot care. For each item on the diet subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate healthier diet.

  2. Summary of Diabetes Self-Care Activities (SDSCA): Diet Subscale Score

    Time frame: Month 3

    The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing, and foot care. For each item on the diet subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate healthier diet.

  3. Summary of Diabetes Self-Care Activities (SDSCA): Diet Subscale Score

    Time frame: Month 6

    The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing, and foot care. For each item on the diet subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate healthier diet.

  4. Summary of Diabetes Self-Care Activities (SDSCA): Diet Subscale Score

    Time frame: Month 9

    The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing, and foot care. For each item on the diet subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate healthier diet.

  5. Summary of Diabetes Self-Care Activities (SDSCA): Diet Subscale Score

    Time frame: Month 12

    The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing, and foot care. For each item on the diet subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate healthier diet.

  6. Summary of Diabetes Self-Care Activities (SDSCA): Exercise Subscale Score

    Time frame: Baseline

    The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing and foot care. For each item on the exercise subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate greater amounts of exercise.

  7. Summary of Diabetes Self-Care Activities (SDSCA): Exercise Subscale Score

    Time frame: Month 3

    The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing and foot care. For each item on the exercise subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate greater amounts of exercise.

  8. Summary of Diabetes Self-Care Activities (SDSCA): Exercise Subscale Score

    Time frame: Month 6

    The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing and foot care. For each item on the exercise subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate greater amounts of exercise.

  9. Summary of Diabetes Self-Care Activities (SDSCA): Exercise Subscale Score

    Time frame: Month 9

    The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing and foot care. For each item on the exercise subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate greater amounts of exercise.

  10. Summary of Diabetes Self-Care Activities (SDSCA): Exercise Subscale Score

    Time frame: Month 12

    The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing and foot care. For each item on the exercise subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate greater amounts of exercise.

  11. Summary of Diabetes Self-Care Activities (SDSCA): Blood-Glucose Testing Subscale Score

    Time frame: Baseline

    The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing and foot care. For each item on the blood-glucose testing subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate more frequent weekly blood-glucose testing.

  12. Summary of Diabetes Self-Care Activities (SDSCA): Blood-Glucose Testing Subscale Score

    Time frame: Month 3

    The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing and foot care. For each item on the blood-glucose testing subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate more frequent weekly blood-glucose testing.

  13. Summary of Diabetes Self-Care Activities (SDSCA): Blood-Glucose Testing Subscale Score

    Time frame: Month 6

    The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing and foot care. For each item on the blood-glucose testing subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate more frequent weekly blood-glucose testing.

  14. Summary of Diabetes Self-Care Activities (SDSCA): Blood-Glucose Testing Subscale Score

    Time frame: Month 9

    The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing and foot care. For each item on the blood-glucose testing subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate more frequent weekly blood-glucose testing.

  15. Summary of Diabetes Self-Care Activities (SDSCA): Blood-Glucose Testing Subscale Score

    Time frame: Month 12

    The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing and foot care. For each item on the blood-glucose testing subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate more frequent weekly blood-glucose testing.

  16. Summary of Diabetes Self-Care Activities (SDSCA): Foot Care Subscale Score

    Time frame: Baseline

    The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing and foot care. For each item on the foot care subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate more frequent completion of foot care activities.

  17. Summary of Diabetes Self-Care Activities (SDSCA): Foot Care Subscale Score

    Time frame: Month 3

    The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing and foot care. For each item on the foot care subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate more frequent completion of foot care activities.

  18. Summary of Diabetes Self-Care Activities (SDSCA): Foot Care Subscale Score

    Time frame: Month 6

    The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing and foot care. For each item on the foot care subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate more frequent completion of foot care activities.

  19. Summary of Diabetes Self-Care Activities (SDSCA): Foot Care Subscale Score

    Time frame: Month 9

    The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing and foot care. For each item on the foot care subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate more frequent completion of foot care activities.

  20. Summary of Diabetes Self-Care Activities (SDSCA): Foot Care Subscale Score

    Time frame: Month 12

    The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing and foot care. For each item on the foot care subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate more frequent completion of foot care activities.

  21. Michigan Diabetes Knowledge Scale Score

    Time frame: Baseline

    20-item assessment of diabetes knowledge. Each item has a potential response of "True," "False," and "I don't know." The total score is the number of correct responses normalized by the total number of items responded, and ranges from 0-1; higher scores indicate greater diabetes knowledge.

  22. Michigan Diabetes Knowledge Scale Score

    Time frame: Month 6

    20-item assessment of diabetes knowledge. Each item has a potential response of "True," "False," and "I don't know." The total score is the number of correct responses normalized by the total number of items responded, and ranges from 0-1; higher scores indicate greater diabetes knowledge.

  23. Michigan Diabetes Knowledge Scale Score

    Time frame: Month 12

    20-item assessment of diabetes knowledge. Each item has a potential response of "True," "False," and "I don't know." The total score is the number of correct responses normalized by the total number of items responded, and ranges from 0-1; higher scores indicate greater diabetes knowledge.

  24. Diabetes Self-Efficacy Scale Score

    Time frame: Baseline

    12-item assessment of participants' confidence in performing certain diabetes-related tasks. For each item, participants select from a Likert scale ranging from 0 (not at all confident) to 10 (very confident). The total score is the sum of responses normalized by the number of items responded and ranges from 0-10; higher scores indicate greater diabetes self-efficacy.

  25. Diabetes Self-Efficacy Scale Score

    Time frame: Month 3

    12-item assessment of participants' confidence in performing certain diabetes-related tasks. For each item, participants select from a Likert scale ranging from 0 (not at all confident) to 10 (very confident). The total score is the sum of responses normalized by the number of items responded and ranges from 0-10; higher scores indicate greater diabetes self-efficacy.

  26. Diabetes Self-Efficacy Scale Score

    Time frame: Month 6

    12-item assessment of participants' confidence in performing certain diabetes-related tasks. For each item, participants select from a Likert scale ranging from 0 (not at all confident) to 10 (very confident). The total score is the sum of responses normalized by the number of items responded and ranges from 0-10; higher scores indicate greater diabetes self-efficacy.

  27. Diabetes Self-Efficacy Scale Score

    Time frame: Month 9

    12-item assessment of participants' confidence in performing certain diabetes-related tasks. For each item, participants select from a Likert scale ranging from 0 (not at all confident) to 10 (very confident). The total score is the sum of responses normalized by the number of items responded and ranges from 0-10; higher scores indicate greater diabetes self-efficacy.

  28. Diabetes Self-Efficacy Scale Score

    Time frame: Month 12

    12-item assessment of participants' confidence in performing certain diabetes-related tasks. For each item, participants select from a Likert scale ranging from 0 (not at all confident) to 10 (very confident). The total score is the sum of responses normalized by the number of items responded and ranges from 0-10; higher scores indicate greater diabetes self-efficacy.

  29. Interpersonal Processes of Care Score Communication Subscale Score

    Time frame: Baseline

    18-item assessment of participants' experiences talking with doctors during the study includes items assessing the following aspects of the IPC: 1) Communication, 2) Decision Making, and 3) Inter-personal style. Each item is rated on a Likert scale from 1 (never) to 5 (always). Scores in negative items are reversed. The total scale score is mean of nonmissing items and ranges from 1-5. Higher scores indicate higher frequency of the construct (higher communication scores indicate better patient-provider communication).

  30. Interpersonal Processes of Care Score Communication Subscale Score

    Time frame: Month 3

    18-item assessment of participants' experiences talking with doctors during the study includes items assessing the following aspects of the IPC: 1) Communication, 2) Decision Making, and 3) Inter-personal style. Each item is rated on a Likert scale from 1 (never) to 5 (always). Scores in negative items are reversed. The total scale score is mean of nonmissing items and ranges from 1-5. Higher scores indicate higher frequency of the construct (higher communication scores indicate better patient-provider communication).

  31. Interpersonal Processes of Care Score Communication Subscale Score

    Time frame: Month 6

    18-item assessment of participants' experiences talking with doctors during the study includes items assessing the following aspects of the IPC: 1) Communication, 2) Decision Making, and 3) Inter-personal style. Each item is rated on a Likert scale from 1 (never) to 5 (always). Scores in negative items are reversed. The total scale score is mean of nonmissing items and ranges from 1-5. Higher scores indicate higher frequency of the construct (higher communication scores indicate better patient-provider communication).

  32. Interpersonal Processes of Care Score Communication Subscale Score

    Time frame: Month 9

    18-item assessment of participants' experiences talking with doctors during the study includes items assessing the following aspects of the IPC: 1) Communication, 2) Decision Making, and 3) Inter-personal style. Each item is rated on a Likert scale from 1 (never) to 5 (always). Scores in negative items are reversed. The total scale score is mean of nonmissing items and ranges from 1-5. Higher scores indicate higher frequency of the construct (higher communication scores indicate better patient-provider communication).

  33. Interpersonal Processes of Care Score Communication Subscale Score

    Time frame: Month 12

    18-item assessment of participants' experiences talking with doctors during the study includes items assessing the following aspects of the IPC: 1) Communication, 2) Decision Making, and 3) Inter-personal style. Each item is rated on a Likert scale from 1 (never) to 5 (always). Scores in negative items are reversed. The total scale score is mean of nonmissing items and ranges from 1-5. Higher scores indicate higher frequency of the construct (higher communication scores indicate better patient-provider communication).

  34. Interpersonal Processes of Care: Decision Making Subscale Score

    Time frame: Baseline

    18-item assessment of participants' experiences talking with doctors during the study includes items assessing the following aspects of the IPC: 1) Communication, 2) Decision Making, and 3) Inter-personal style. Each item is rated on a Likert scale from 1 (never) to 5 (always). Scores in negative items were reversed. Total scale score is mean of nonmissing items and ranges from 1-5. Higher scores indicate higher frequency of the construct (higher decision making scores indicate more decision making).

  35. Interpersonal Processes of Care: Decision Making Subscale Score

    Time frame: Month 3

    18-item assessment of participants' experiences talking with doctors during the study includes items assessing the following aspects of the IPC: 1) Communication, 2) Decision Making, and 3) Inter-personal style. Each item is rated on a Likert scale from 1 (never) to 5 (always). Scores in negative items were reversed. Total scale score is mean of nonmissing items and ranges from 1-5. Higher scores indicate higher frequency of the construct (higher decision making scores indicate more decision making).

  36. Interpersonal Processes of Care: Decision Making Subscale Score

    Time frame: Month 6

    18-item assessment of participants' experiences talking with doctors during the study includes items assessing the following aspects of the IPC: 1) Communication, 2) Decision Making, and 3) Inter-personal style. Each item is rated on a Likert scale from 1 (never) to 5 (always). Scores in negative items were reversed. Total scale score is mean of nonmissing items and ranges from 1-5. Higher scores indicate higher frequency of the construct (higher decision making scores indicate more decision making).

  37. Interpersonal Processes of Care: Decision Making Subscale Score

    Time frame: Month 9

    18-item assessment of participants' experiences talking with doctors during the study includes items assessing the following aspects of the IPC: 1) Communication, 2) Decision Making, and 3) Inter-personal style. Each item is rated on a Likert scale from 1 (never) to 5 (always). Scores in negative items were reversed. Total scale score is mean of nonmissing items and ranges from 1-5. Higher scores indicate higher frequency of the construct (higher decision making scores indicate more decision making).

  38. Interpersonal Processes of Care: Decision Making Subscale Score

    Time frame: Month 12

    18-item assessment of participants' experiences talking with doctors during the study includes items assessing the following aspects of the IPC: 1) Communication, 2) Decision Making, and 3) Inter-personal style. Each item is rated on a Likert scale from 1 (never) to 5 (always). Scores in negative items were reversed. Total scale score is mean of nonmissing items and ranges from 1-5. Higher scores indicate higher frequency of the construct (higher decision making scores indicate more decision making).

  39. Interpersonal Processes of Care: Inter-personal Style Subscale Score

    Time frame: Baseline

    18-item assessment of participants' experiences talking with doctors during the study includes items assessing the following aspects of the IPC: 1) Communication, 2) Decision Making, and 3) Inter-personal style. Each item is rated on a Likert scale from 1 (never) to 5 (always). Scores in negative items were reversed. Total scale score is mean of nonmissing items and ranges from 1-5. Higher scores indicate higher frequency of the construct (higher inter-personal style scores indicate more inter-personal style).

  40. Interpersonal Processes of Care: Inter-personal Style Subscale Score

    Time frame: Month 3

    18-item assessment of participants' experiences talking with doctors during the study includes items assessing the following aspects of the IPC: 1) Communication, 2) Decision Making, and 3) Inter-personal style. Each item is rated on a Likert scale from 1 (never) to 5 (always). Scores in negative items were reversed. Total scale score is mean of nonmissing items and ranges from 1-5. Higher scores indicate higher frequency of the construct (higher inter-personal style scores indicate more inter-personal style).

  41. Interpersonal Processes of Care: Inter-personal Style Subscale Score

    Time frame: Month 6

    18-item assessment of participants' experiences talking with doctors during the study includes items assessing the following aspects of the IPC: 1) Communication, 2) Decision Making, and 3) Inter-personal style. Each item is rated on a Likert scale from 1 (never) to 5 (always). Scores in negative items were reversed. Total scale score is mean of nonmissing items and ranges from 1-5. Higher scores indicate higher frequency of the construct (higher inter-personal style scores indicate more inter-personal style).

  42. Interpersonal Processes of Care: Inter-personal Style Subscale Score

    Time frame: Month 9

    18-item assessment of participants' experiences talking with doctors during the study includes items assessing the following aspects of the IPC: 1) Communication, 2) Decision Making, and 3) Inter-personal style. Each item is rated on a Likert scale from 1 (never) to 5 (always). Scores in negative items were reversed. Total scale score is mean of nonmissing items and ranges from 1-5. Higher scores indicate higher frequency of the construct (higher inter-personal style scores indicate more inter-personal style).

  43. Interpersonal Processes of Care: Inter-personal Style Subscale Score

    Time frame: Month 12

    18-item assessment of participants' experiences talking with doctors during the study includes items assessing the following aspects of the IPC: 1) Communication, 2) Decision Making, and 3) Inter-personal style. Each item is rated on a Likert scale from 1 (never) to 5 (always). Scores in negative items were reversed. Total scale score is mean of nonmissing items and ranges from 1-5. Higher scores indicate higher frequency of the construct (higher inter-personal style scores indicate more inter-personal style).

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Aug 29, 2018
Registry last updated
Feb 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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