Self-Management Interventions Using Mobile Health for the Multimorbid

Multiple Chronic Conditions Clinical Trial

Official title:

Self-Management Interventions Using Mobile Health for the Multimorbid

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04566107
• Other study ID #: 0445-18-EP
• Status: Completed
• Phase: N/A
• Start date: October 14, 2019
• Est. completion date: June 30, 2021

Study information

• Verified date: September 2023
• Source: University of Nebraska
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Disease
• Multiple Chronic Conditions

Intervention

Behavioral:
• mHealth intervention
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 Plus
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.

Locations

Country	Name	City	State
United States	University of Nebraska Medical Center, College of Nursing	Lincoln	Nebraska

Sponsors (2)

Lead Sponsor	Collaborator
University of Nebraska	Greater Plains Collaborative Clinical Data Research Network

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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)	30 days after intervention initiated
Secondary	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)	60 days after intervention initiated
Secondary	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)	90 days after intervention initiated
Secondary	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)	30 days after intervention initiated
Secondary	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)	60 days after intervention initiated
Secondary	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)	90 days after intervention initiated
Secondary	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)	30 days after intervention initiated
Secondary	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)	60 days after intervention initiated
Secondary	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)	90 days after intervention initiated
Secondary	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)	30 days after intervention initiated
Secondary	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)	60 days after intervention initiated
Secondary	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)	90 days after intervention initiated
Secondary	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)	30 days after intervention initiated
Secondary	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	60 days after intervention initiated
Secondary	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	90 days after intervention initiated
Secondary	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	30 days after intervention initiated
Secondary	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	60 days after intervention initiated
Secondary	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	90 days after intervention initiated
Secondary	Emergency rooms visits and re-hospitalizations assessed by frequency and percent assessed by reviewing the electronic medical record	measure of health care utilization	30 days after intervention initiated
Secondary	Emergency rooms visits and re-hospitalizations assessed by frequency and percent assessed by reviewing the electronic medical record	measure of health care utilization	60 days after intervention initiated
Secondary	Emergency rooms visits and re-hospitalizations assessed by frequency and percent assessed by reviewing the electronic medical record	measure of health care utilization	90 days after intervention initiated