Clinical trial NCT04566107: Self-Management Interventions Using Mobile Health for the Multimorbid
Official title: Self-Management Interventions Using Mobile Health for the Multimorbid
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Chronic Conditions
Keywords: multiple chronic conditions
mobile health
multimorbidity
Lead sponsor: University of Nebraska
Sponsor class: OTHER
Collaborators: name: Greater Plains Collaborative Clinical Data Research Network
First posted: 2020-09-28
Enrollment: 63
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Usability and acceptability of the self-management interventions by administering a Usability and Acceptability tool
timeFrame: 60 days after enrolled
measure: Enrollment of participants to the comparative self-management (SM) interventions by calculating frequency and percentage of available participants and enrolled participants.
timeFrame: 90 days after enrolled
measure: Number of times the participant records activities within the application.
timeFrame: 90 days after enrollment
Secondary outcomes:
measure: Frequency and percent of the participants recording a weight in pounds in the mHealth app
timeFrame: 30 days after intervention initiated
measure: Frequency and percent of the participants recording a weight in pounds in the mHealth app
timeFrame: 60 days after intervention initiated
measure: Frequency and percent of the participants recording a weight in pounds in the mHealth app
timeFrame: 90 days after intervention initiated
measure: Frequency and percent of the participants recording a blood pressure (BP) in the mHealth app
timeFrame: 30 days after intervention initiated
measure: Frequency and percent of the participants recording a blood pressure (BP) in the mHealth app
timeFrame: 60 days after intervention initiated
measure: Frequency and percent of the participants recording a blood pressure (BP) in the mHealth app
timeFrame: 90 days after intervention initiated
measure: Frequency and percent of the participants recording a pulse oximetry in the mHealth app
timeFrame: 30 days after intervention initiated
measure: Frequency and percent of the participants recording a pulse oximetry in the mHealth app
timeFrame: 60 days after intervention initiated
measure: Frequency and percent of the participants recording a pulse oximetry in the mHealth app
timeFrame: 90 days after intervention initiated
measure: Frequency and percent of the participants recording a blood glucose in the mHealth app
timeFrame: 30 days after intervention initiated
measure: Frequency and percent of the participants recording a blood glucose in the mHealth app
timeFrame: 60 days after intervention initiated
measure: Frequency and percent of the participants recording a blood glucose in the mHealth app
timeFrame: 90 days after intervention initiated
measure: 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.
timeFrame: 30 days after intervention initiated
measure: 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.
timeFrame: 60 days after intervention initiated
measure: 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.
timeFrame: 90 days after intervention initiated
measure: 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
timeFrame: 30 days after intervention initiated
measure: 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
timeFrame: 60 days after intervention initiated
measure: 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
timeFrame: 90 days after intervention initiated
measure: Emergency rooms visits and re-hospitalizations assessed by frequency and percent assessed by reviewing the electronic medical record
timeFrame: 30 days after intervention initiated
measure: Emergency rooms visits and re-hospitalizations assessed by frequency and percent assessed by reviewing the electronic medical record
timeFrame: 60 days after intervention initiated
measure: Emergency rooms visits and re-hospitalizations assessed by frequency and percent assessed by reviewing the electronic medical record
timeFrame: 90 days after intervention initiated
Other outcomes:
Locations:
city: Lincoln
country: United States
facility: University of Nebraska Medical Center, College of Nursing
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Myra S Schmaderer, PhD
role: PRINCIPAL_INVESTIGATOR
References: