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Self-Management Interventions Using Mobile Health for the Multimorbid

Primary Purpose

Multiple Chronic Conditions

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
mHealth intervention
mHealth Plus
Sponsored by
University of Nebraska
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Multiple Chronic Conditions focused on measuring multiple chronic conditions, mobile health, multimorbidity

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Nebraska Medical Center, College of Nursing

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Enhanced Usual Care

mHealth

mHealth Plus

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Usability and acceptability of the self-management interventions by administering a Usability and Acceptability tool
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.
measure of enrollment and recruitment
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

Secondary Outcome Measures

Frequency and percent of the participants recording a weight in pounds in the mHealth app
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 weight in pounds in the mHealth app
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 weight in pounds in the mHealth app
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 pressure (BP) in the mHealth app
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 blood pressure (BP) in the mHealth app
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 blood pressure (BP) in the mHealth app
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 pulse oximetry in the mHealth app
monitoring of physiological measures for each of the physiologic parameters appropriate for the participants chronic disease. (number of oximetry readings recorded for chronic obstructive pulmonary disease (COPD) participant)
Frequency and percent of the participants recording a pulse oximetry in the mHealth app
monitoring of physiological measures for each of the physiologic parameters appropriate for the participants chronic disease (number of oximetry readings recorded for (COPD) participant)
Frequency and percent of the participants recording a pulse oximetry in the mHealth app
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)
Frequency and percent of the participants recording a blood glucose in the mHealth app
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)
Frequency and percent of the participants recording a blood glucose in the mHealth app
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)
Frequency and percent of the participants recording a blood glucose in the mHealth app
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.
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.
Measure of quality of life
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.
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
Measure of health status and symptoms
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
measure of health status and symptoms
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
measure of health status and symptoms
Emergency rooms visits and re-hospitalizations assessed by frequency and percent assessed by reviewing the electronic medical record
measure of health care utilization
Emergency rooms visits and re-hospitalizations assessed by frequency and percent assessed by reviewing the electronic medical record
measure of health care utilization
Emergency rooms visits and re-hospitalizations assessed by frequency and percent assessed by reviewing the electronic medical record
measure of health care utilization

Full Information

First Posted
May 4, 2020
Last Updated
September 22, 2023
Sponsor
University of Nebraska
Collaborators
Greater Plains Collaborative Clinical Data Research Network
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1. Study Identification

Unique Protocol Identification Number
NCT04566107
Brief Title
Self-Management Interventions Using Mobile Health for the Multimorbid
Official Title
Self-Management Interventions Using Mobile Health for the Multimorbid
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
October 14, 2019 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
June 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nebraska
Collaborators
Greater Plains Collaborative Clinical Data Research Network

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Chronic Conditions
Keywords
multiple chronic conditions, mobile health, multimorbidity

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
No masking
Allocation
Randomized
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Enhanced Usual Care
Arm Type
No Intervention
Arm Description
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.
Arm Title
mHealth
Arm Type
Experimental
Arm Description
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.
Arm Title
mHealth Plus
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
mHealth intervention
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
mHealth Plus
Intervention Description
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.
Primary Outcome Measure Information:
Title
Usability and acceptability of the self-management interventions by administering a Usability and Acceptability tool
Description
A Usability and Acceptability investigator developed tool.
Time Frame
60 days after enrolled
Title
Enrollment of participants to the comparative self-management (SM) interventions by calculating frequency and percentage of available participants and enrolled participants.
Description
measure of enrollment and recruitment
Time Frame
90 days after enrolled
Title
Number of times the participant records activities within the application.
Description
Measurement of engagement with the application, participant records will be downloaded from the application and frequency and percent will be calculated
Time Frame
90 days after enrollment
Secondary Outcome Measure Information:
Title
Frequency and percent of the participants recording a weight in pounds in the mHealth app
Description
monitoring of physiological measures for each of the physiologic parameters appropriate for the participants chronic disease (number of weights recorded for heart failure participant)
Time Frame
30 days after intervention initiated
Title
Frequency and percent of the participants recording a weight in pounds in the mHealth app
Description
monitoring of physiological measures for each of the physiologic parameters appropriate for the participants chronic disease (number of weights recorded for heart failure participant)
Time Frame
60 days after intervention initiated
Title
Frequency and percent of the participants recording a weight in pounds in the mHealth app
Description
monitoring of physiological measures for each of the physiologic parameters appropriate for the participants chronic disease (number of weights recorded for heart failure participant)
Time Frame
90 days after intervention initiated
Title
Frequency and percent of the participants recording a blood pressure (BP) in the mHealth app
Description
monitoring of physiological measures for each of the physiologic parameters appropriate for the participants chronic disease (number of BP recorded for hypertension participant)
Time Frame
30 days after intervention initiated
Title
Frequency and percent of the participants recording a blood pressure (BP) in the mHealth app
Description
monitoring of physiological measures for each of the physiologic parameters appropriate for the participants chronic disease (number of BP recorded for hypertension participant)
Time Frame
60 days after intervention initiated
Title
Frequency and percent of the participants recording a blood pressure (BP) in the mHealth app
Description
monitoring of physiological measures for each of the physiologic parameters appropriate for the participants chronic disease (number of BP recorded for hypertension participant)
Time Frame
90 days after intervention initiated
Title
Frequency and percent of the participants recording a pulse oximetry in the mHealth app
Description
monitoring of physiological measures for each of the physiologic parameters appropriate for the participants chronic disease. (number of oximetry readings recorded for chronic obstructive pulmonary disease (COPD) participant)
Time Frame
30 days after intervention initiated
Title
Frequency and percent of the participants recording a pulse oximetry in the mHealth app
Description
monitoring of physiological measures for each of the physiologic parameters appropriate for the participants chronic disease (number of oximetry readings recorded for (COPD) participant)
Time Frame
60 days after intervention initiated
Title
Frequency and percent of the participants recording a pulse oximetry in the mHealth app
Description
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)
Time Frame
90 days after intervention initiated
Title
Frequency and percent of the participants recording a blood glucose in the mHealth app
Description
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)
Time Frame
30 days after intervention initiated
Title
Frequency and percent of the participants recording a blood glucose in the mHealth app
Description
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)
Time Frame
60 days after intervention initiated
Title
Frequency and percent of the participants recording a blood glucose in the mHealth app
Description
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)
Time Frame
90 days after intervention initiated
Title
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.
Description
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)
Time Frame
30 days after intervention initiated
Title
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.
Description
Measure of quality of life
Time Frame
60 days after intervention initiated
Title
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.
Description
measure of quality of life
Time Frame
90 days after intervention initiated
Title
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
Description
Measure of health status and symptoms
Time Frame
30 days after intervention initiated
Title
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
Description
measure of health status and symptoms
Time Frame
60 days after intervention initiated
Title
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
Description
measure of health status and symptoms
Time Frame
90 days after intervention initiated
Title
Emergency rooms visits and re-hospitalizations assessed by frequency and percent assessed by reviewing the electronic medical record
Description
measure of health care utilization
Time Frame
30 days after intervention initiated
Title
Emergency rooms visits and re-hospitalizations assessed by frequency and percent assessed by reviewing the electronic medical record
Description
measure of health care utilization
Time Frame
60 days after intervention initiated
Title
Emergency rooms visits and re-hospitalizations assessed by frequency and percent assessed by reviewing the electronic medical record
Description
measure of health care utilization
Time Frame
90 days after intervention initiated

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Myra S Schmaderer, PhD
Organizational Affiliation
University of Nebraska
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Nebraska Medical Center, College of Nursing
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68588
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Self-Management Interventions Using Mobile Health for the Multimorbid

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