NCT03834428

Brief Summary

The investigators plan to conduct a study that evaluates if text messaging increases patients' adherence to ambulation (specifically reminding patients to get out of bed three or more times daily) which is one component of a protocol called ICOUGH, which is a mnemonic that stands for: Incentive spirometry (a breathing device that expands the lungs), Coughing and deep breathing, Oral hygiene (using a toothbrush for example),Understanding (patient and family education), Getting out of bed at least three times daily, and Head-of-bed elevation to prevent choking; each letter representing steps of a protocol developed at Boston Medical Center (BMC) shown to decrease lung-related complications of surgery. Other outcomes, including frequency of ambulation, pain score, number of visitors per day, head-of-bed elevation, education on importance of ambulation, and falls will also be assessed. The hypothesis is that a reminder text message to ambulate will improve these outcomes over time. While beneficial to patients and health care facilities, the ICOUGH protocol is sometimes both difficult to implement and sustain at an acute care hospital, because: (1) patient motivation fluctuates and is the key determinant of patient ambulation (2) it relies heavily on nurses to both educate patients and then keep them accountable to the protocol, (3) an unfavorable nurse-to-patient ratio, (4) high inpatient turnover for elective surgical cases, and (5) an aging baby boomer population-a higher volume of older, higher- risk patients will require more time and attention per nurse. Therefore, utilization of text message reminders may promote better patient, family, and provider engagement and adherence to ambulation which can improve outcomes and decrease healthcare spending.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 5, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 8, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

March 21, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 7, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 13, 2019

Completed
Last Updated

July 16, 2019

Status Verified

July 1, 2019

Enrollment Period

3 months

First QC Date

February 5, 2019

Last Update Submit

July 14, 2019

Conditions

Keywords

Text message reminderICOUGH protocolITextSafety net hospitalInpatient

Outcome Measures

Primary Outcomes (1)

  • Change in the frequency of ambulation daily while hospitalized

    The frequency of ambulation will be tracked for each participant each day of their hospitalization after ICOUGH education. Ambulation is defined as leaving a patient's room.

    baseline and 10 days

Secondary Outcomes (6)

  • Pain Level Scale twice daily while hospitalized

    Twice daily until hospital discharge or for 10 days maximum

  • Number of participants that received ambulation education during hospitalization

    At hospital discharge or hospital day #10

  • Daily chair usage during hospitalization

    Daily until hospital discharge or for 10 days maximum

  • Number of daily visitors while hospitalized

    Daily until hospital discharge or for 10 days maximum

  • Number of visitors who helped participants ambulate

    Daily until hospital discharge or for 10 days maximum

  • +1 more secondary outcomes

Study Arms (2)

No Text Message Control

ACTIVE COMPARATOR

Participants randomized to this arm will receive education about the ICOUGH protocol which includes the importance of ambulation.

Behavioral: ICOUGH protocol

Text Message Intervention

EXPERIMENTAL

Participants randomized to this arm will receive daily text message reminders to ambulate in the hospital in addition to education about the ICOUGH protocol which includes the importance of ambulation.

Behavioral: Text Message InterventionBehavioral: ICOUGH protocol

Interventions

A text message will be sent once daily (between noon and 3p) to remind participants to ambulate at least 3 times each day while hospitalized.

Text Message Intervention
ICOUGH protocolBEHAVIORAL

Education will be provided about the ICOUGH protocol which includes: Incentive spirometry (a breathing device that expands the lungs), Coughing and deep breathing, Oral hygiene (for example using a toothbrush), Understanding (patient and family education), Getting out of bed at least three times daily, and Head-of-bed elevation to prevent choking.

No Text Message ControlText Message Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients of all genders on any surgical service at Boston Medical Center
  • English speaking
  • Ability to read at 5th grade level
  • Able to ambulate, with or without assistance
  • Possession of a personal cell phone that can receive text messages

You may not qualify if:

  • Visually impaired or blind
  • Presence of neuromuscular disease or inability to perform all the measures in the ICOUGH protocol
  • Prisoners
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Mobility Limitation

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Pamela Rosenkranz

    Boston University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2019

First Posted

February 8, 2019

Study Start

March 21, 2019

Primary Completion

June 7, 2019

Study Completion

July 13, 2019

Last Updated

July 16, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations