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Clinical Trials/NCT04566107
NCT04566107
Completed
N/A

Self-Management Interventions Using Mobile Health for the Multimorbid

University of Nebraska1 site in 1 country63 target enrollmentOctober 14, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Multiple Chronic Conditions
Sponsor
University of Nebraska
Enrollment
63
Locations
1
Primary Endpoint
Number of times the participant records activities within the application.
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 14, 2019
End Date
June 30, 2021
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

Number of times the participant records activities within the application.

Time Frame: 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

Time Frame: 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.

Time Frame: 90 days after enrolled

measure of enrollment and recruitment

Secondary Outcomes

  • Frequency and percent of the participants recording a pulse oximetry in the mHealth app(90 days after intervention initiated)
  • Emergency rooms visits and re-hospitalizations assessed by frequency and percent assessed by reviewing the electronic medical record(90 days after intervention initiated)
  • 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)
  • Frequency and percent of the participants recording a blood pressure (BP) in the mHealth app(90 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 glucose in the mHealth app(90 days after intervention initiated)
  • 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)
  • 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)

Study Sites (1)

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