Digital Care's Burden on Patients

Overview

About this study

The purpose of this study is to evaluate the burdensome aspects of digital healthcare for a diverse range of chronic patients with varying levels of digital comfort.

The study will have three phases:

interviewing up to 40 patients to elicit content related to the burden of digital interventions for healthcare self-management (DRx) and understand how well the current TBQ capture it (Aim 1a);
patient-centered, iterative development (i.e., item generation), cognitive testing, and refinement of an adapted TBQ that addresses DRx (Aim 1b); and
field testing of DRx TBQ to test its validity (Aim 2).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

Age ≥ 18 years.
A clinician-diagnosed Type 1, Type 2, or gestational diabetes.
Receiving diabetes care by any clinician at the Division of Endocrinology.
Use any treatment to achieve glycemic control.
Users of any form of digital device or software for diabetes management.
Ability to read, speak, and understand English.
Access to telephone/videoconferencing technology for interviews or ability to meet study staff in person for an interview.
Ability and willingness to participate in all study related surveys and questionnaires.

Exclusion Criteria:

Patients for whom caregivers are the main users of digital tools in support of the patient’s care.
Participants who, in the opinion of the research staff, exhibit clinically significant cognitive or memory (e.g., the participant has trouble holding a conversation, or the participant exhibits signs of disorientation) or sensorial impairment that limits the participant’s ability to give informed consent.

Eligibility last updated 7/26/23. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status	Contact
Rochester, Minn. Mayo Clinic principal investigator Victor Montori, M.D.	Open for enrollment	Contact information: Misk Al Zahidy M.S. (507) 255-0241 alzahidy.misk@mayo.edu

Mayo Clinic Location

Status

Contact

Rochester, Minn.

Mayo Clinic principal investigator

Victor Montori, M.D.

Open for enrollment

Contact information:

Misk Al Zahidy M.S.

(507) 255-0241

alzahidy.misk@mayo.edu

More information

Publications

Publications are currently not available

Clinical Trials