Self-Management Interventions Using Mobile Health for the Multimorbid

NCT04566107 | Completed

• 1 other identifier: 0445-18-EP
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this pilot study is to evaluate the feasibility and impact of delivering mobile health self-management interventions to improve adherence to the prescribed treatment in a multimorbid population returning home after hospital discharge.

Conditions

Multiple Chronic Conditions

Keywords

multiple chronic conditions; mobile health; multimorbidity

Outcome Measures

Primary Outcomes (3)

• Usability and acceptability of the self-management interventions by administering a Usability and Acceptability tool

  A Usability and Acceptability investigator developed tool.

  60 days after enrolled

• Enrollment of participants to the comparative self-management (SM) interventions by calculating frequency and percentage of available participants and enrolled participants.

  measure of enrollment and recruitment

  90 days after enrolled

• Number of times the participant records activities within the application.

  Measurement of engagement with the application, participant records will be downloaded from the application and frequency and percent will be calculated

  90 days after enrollment

Secondary Outcomes (21)

• Frequency and percent of the participants recording a weight in pounds in the mHealth app

  30 days after intervention initiated

• Frequency and percent of the participants recording a weight in pounds in the mHealth app

  60 days after intervention initiated

• Frequency and percent of the participants recording a weight in pounds in the mHealth app

  90 days after intervention initiated

• Frequency and percent of the participants recording a blood pressure (BP) in the mHealth app

  30 days after intervention initiated

• Frequency and percent of the participants recording a blood pressure (BP) in the mHealth app

  60 days after intervention initiated

Study Arms (3)

Enhanced Usual Care

NO INTERVENTION

The enhanced usual care group will receive evidence-based standardized disease-specific education based on discharge protocols. In addition, individuals in the enhanced usual care group will receive the mobile health platform to record medications taken and BlueTooth devices to record physiologic measurements.

mHealth

EXPERIMENTAL

The mHealth group will receive evidence-based standardized disease-specific education based on discharge protocols. In addition, the mHealth group will receive the mobile health platform with reminders to take medications and engage in an educational tip. Subjects receive BlueTooth devices to record physiologic measurements.

Behavioral: mHealth intervention

mHealth Plus

EXPERIMENTAL

The mHealth group plus will receive evidence-based standardized disease-specific education based on discharge protocols. In addition, the mHealth plus group will receive the mobile health platform with reminders to take medications and engage in an educational tip. Participants receive BlueTooth devices to record physiologic measurements. The m-Health Plus group will receive real-time virtual visits with a nurse practitioner/community health worker team. Virtual visits are similar to an office follow-up visit with an health care provider using Zoom technology to allow for face-to-face interaction with the patient.

Behavioral: mHealth Plus

Interventions

mHealth intervention BEHAVIORAL

The intervention promotes self-management and adherence to treatment regimens in patients with multimorbidity. This 8-week SM intervention uses mobile health (m-Health) technology for daily messages and reminders to promote self-monitoring activities. Bluetooth devices provided will depend on the participant's need for self-management; heart failure (scale), diabetes (glucometer), COPD (pulse oximeter) or hypertension (BP machine).

mHealth

mHealth Plus BEHAVIORAL

The intervention promotes self-management and adherence to treatment regimens in patients with multimorbidity. This 8-week SM intervention uses tailored self-management strategies (action planning, goal setting, and individual identified support needs) and mobile health (m-Health) technology for virtual visits, daily messages, and self-monitoring activities. The investigators will test the additive impact of having the nurse practitioner/community health worker (NP/CHW) team with the m-health platform. The NP will evaluate physiological and psychosocial status while the CHW will assist in recognizing possible solutions to challenging social determinants of health by identifying community resources and guidance in overcoming barriers. Bluetooth devices provided will depend on the participant's need for self-management; heart failure (scale), diabetes (glucometer), COPD (pulse oximeter) or hypertension (BP machine). Participants will receive reminders through the platform.

mHealth Plus

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• multimorbid patients with one of 4 chronic conditions (HF, COPD, diabetes or hypertension) and have at least one other chronic disease (i.e., hypertension, cancer, stroke, heart disease, diabetes, arthritis, hepatitis, current asthma, kidney failure, or COPD),
• adult patients (age 19 and older)
• access to smart technology (phone or iPad) and internet access or a phone plan large enough for daily interactions; and d) able to hear, speak and read English.

You may not qualify if:

• major surgery while admitted;
• discharged to somewhere other than home (e.g., long term care facility);
• receiving home health services;
• documented dementia; and
• life expectancy \<6 months.

Sponsors & Collaborators

• University of Nebraska: lead
• Greater Plains Collaborative Clinical Data Research Network: collaborator

Study Sites (1)

University of Nebraska Medical Center, College of Nursing

Lincoln, Nebraska, 68588, United States

Location

MeSH Terms

Conditions

Multiple Chronic Conditions

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Myra S Schmaderer, PhD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2020
• First Posted: September 28, 2020
• Study Start: October 14, 2019
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: September 26, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)