Self-Management Interventions Using Mobile Health for the Multimorbid

Not Applicable

Completed

• Conditions: Multiple Chronic Conditions
• Interventions: Behavioral: mHealth intervention; Behavioral: mHealth Plus

• Registration Number: NCT04566107
• Lead Sponsor: University of Nebraska

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.

Detailed Description

The purpose of this three-group repeated-measures randomized controlled trial is to evaluate the use of mobile health (mHealth) self-management technology as a model of care for individuals with multimorbidity. Specifically, this 8-week self-management intervention uses tailored self-management strategies (action planning, goal setting, and individually identified support needs) and mHealth technology for real-time virtual visits, daily messages, and self-monitoring activities. The investigators are testing the additive impact of having the nurse practitioner/community health worker (NP/CHW) team with the mHealth platform (mHealth Plus). The NP evaluates physiological status by evaluating symptoms and tailoring the intervention specific to the individual's multimorbidity while the CHW will assist in recognizing possible solutions to challenging social determinants of health by identifying community resources and guidance in overcoming barriers.

The following specific aims will be addressed:

Aim 1: To evaluate the feasibility of implementing comparative SM interventions (mHealth and mHealth plus virtual visits with a nurse practitioner and community health worker team) in multimorbid individuals by assessing: a) acceptability of each intervention; b) enrollment (recruitment efficiency, attrition, problems and solutions); c) intervention fidelity (delivery, receipt, enactment of the intervention \[benefits and barriers\]); and d) data collection (technological transfer of data, instrument reliability, the time required, missing data).

Aim 2: To examine the impact of delivering the m-Health and m-Health plus interventions compared to standard care (SC) in multimorbid individuals on: a) primary outcome: adherence to disease-specific lifestyle behaviors (e.g. diet and medication, and self-monitoring of physiological measures as needed (e.g. weight blood pressure, blood glucose, oxygen saturation); b) secondary outcomes: health related quality of life; c) patient-reported health status; d) symptom status; and e) healthcare utilization.

Study Timeline

• Study Start: 2019-10-14
• Study First Submitted: 2020-05-04
• Study First Submitted QC: 2020-09-21
• Study First Posted: 2020-09-28
• Primary Completion: 2021-06-30
• Study Completion: 2021-06-30
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-22
• Last Update Posted: 2023-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

Inclusion Criteria

1. 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),
2. adult patients (age 19 and older)
3. 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.

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
mHealth	mHealth intervention	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.
mHealth Plus	mHealth Plus	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.

Primary Outcome Measures

Name	Time	Method
Number of times the participant records activities within the application.	90 days after enrollment	Measurement of engagement with the application, participant records will be downloaded from the application and frequency and percent will be calculated
Usability and acceptability of the self-management interventions by administering a Usability and Acceptability tool	60 days after enrolled	A Usability and Acceptability investigator developed tool.
Enrollment of participants to the comparative self-management (SM) interventions by calculating frequency and percentage of available participants and enrolled participants.	90 days after enrolled	measure of enrollment and recruitment

Secondary Outcome Measures

Name	Time	Method
Frequency and percent of the participants recording a pulse oximetry in the mHealth app	90 days after intervention initiated	monitoring of physiological measures for each of the physiologic parameters appropriate for the participants chronic disease (number of oximetry readings recorded for the chronic obstructive pulmonary disease (COPD) participant)
Emergency rooms visits and re-hospitalizations assessed by frequency and percent assessed by reviewing the electronic medical record	90 days after intervention initiated	measure of health care utilization
Patient Reported Outcomes Measurement Information System PROMIS® (Promis29 V2.0) score of mobility, self-care, usual activities, pain/ discomfort, anxiety/ depression and a visual analogue scale rating of health today	90 days after intervention initiated	measure of health status and symptoms
Frequency and percent of the participants recording a blood pressure (BP) in the mHealth app	90 days after intervention initiated	monitoring of physiological measures for each of the physiologic parameters appropriate for the participants chronic disease (number of BP recorded for hypertension participant)
Frequency and percent of the participants recording a weight in pounds in the mHealth app	90 days after intervention initiated	monitoring of physiological measures for each of the physiologic parameters appropriate for the participants chronic disease (number of weights recorded for heart failure participant)
Frequency and percent of the participants recording a blood glucose in the mHealth app	90 days after intervention initiated	monitoring of physiological measures for each of the physiologic parameters appropriate for the participants chronic disease (number of blood glucose readings recorded for the diabetic participant)
Health related quality of life assessed by the EQ-5D-5L developed by the EuroQol group scored as an index and a visual analogue scale.	90 days after intervention initiated	measure of quality of life
Patient Reported Outcomes Measurement Information System (PROMIS®) (Promis29 V2.0) score of mobility, self-care, usual activities, pain/ discomfort, anxiety/ depression and a visual analogue scale rating of health today	30 days after intervention initiated	Measure of health status and symptoms

Trial Locations

Locations (1)

University of Nebraska Medical Center, College of Nursing; 🇺🇸 Lincoln, Nebraska, United States