Home Telemonitoring for Patients With Lung Cancer

NCT01670539 | Completed Results DMC

• 2 other identifiers: H-229301R15CA150999
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to learn more about using a home machine "Telemonitor" to find problems people with lung cancer may have after being discharged from the hospital and help them manage problems by contacting their healthcare provider.The study hypothesis is that patients with lung CA using short-term (14 days)home telemonitors, educated/coached by nurses on telemonitor data risks/implications for the first two weeks after hospital discharge, will be able to self-report their signs/ symptoms to the clinician resulting in decreased use of costly health care resources over 60 days.

Conditions

Lung Cancer

Keywords

Lung Cancer; Telemonitoring; Rural; Nursing

Outcome Measures

Primary Outcomes (5)

• Changes in Telemonitor Data From Baseline: Temperature

  Changes in temperature measured by telemonitor daily over 14 days after hospital discharge

  14 days

• Changes in Telemonitor Data From Baseline: Pulse Rate

  Changes in pulse rate measured by telemonitor daily over 14 days after hospital discharge

  14 days

• Changes in Telemonitor Data From Baseline: Blood Pressure

  Changes in blood pressure measured by telemonitor daily over 14 days after hospital discharge

  14 days

• Changes in Telemonitor Data From Baseline: SpO2

  Changes in SpO2 measured by telemonitor daily over 14 days after hospital discharge

  14 days

• Changes in Telemonitor Data From Baseline: Weight

  Changes in weight measured by telemonitor daily over 14 days after hospital discharge

  14 days

Secondary Outcomes (3)

• Changes in Telemonitor Symptoms Recorded From Baseline: Dyspnea

  14 days

• Changes in Telemonitor Symptoms Recorded From Baseline: Functioning

  14 days

• Changes in Telemonitor Symptoms Recorded From Baseline: Pain

  14 days

Study Arms (2)

Telemonitor

EXPERIMENTAL

In addition to routine care, the "HomMed Telemonitor" wireless telemonitoring system (intervention)will be used in the patient's home for 14 days to alert the clinical research nurse to changes in patients conditions in order to contact them to teach self-management. The Honeywell HomMed Genesis™ DM Remote Patient Care Monitor will be used to measure temperature, pulse, oxygen level,weight and blood pressure. The telemonitor will also ask for a YES or NO response to questions on symptoms such as difficulty breathing. Research nurses review the data daily and call the participant for 2 weeks, and continue to monitor outcomes for 2 months.

Device: HomMed Telemonitor

Routine care for patients with lungCa

NO INTERVENTION

Traditional physician ordered post-hospital care for patients with lung CA in rural WV requires patients to make an outpatient office/ clinic visit two to three weeks after discharge;a few patients receive homecare service referrals. No attempt to change care - just monitor what is used and collect study data at Discharge, 2 weeks, one month and two months.

Interventions

HomMed Telemonitor DEVICE

A "HomMed Telemonitor" wireless telemonitoring system collects data on a daily basis, including heart rate, blood pressure, oxygen level, body temperature, weight, responses to 9 pre-programmed questions (including difficulty breathing, fatigue, limited activities, difficulty taking meds, pain). Telemonitored results are transmitted to the research office for analysis and contact to patient by clinical research nurses.

Also known as: Honeywell HomMed Genesis™ DM Remote Patient Care Monitor, http://hommed.com/Products/Genesis_DM.asp

Telemonitor

Eligibility Criteria

• Age: 45 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (1) patients admitted to the hospital for lung CA as a primary or secondary diagnosis; (2) at least 45 years of age and up to 90 years old; (3) stable mental status and ability to speak (but not necessarily read) the primary language of the region (English).

You may not qualify if:

• are not discharged to home settings
• are discharged to hospice
• display a verbalized inability to understand or answer the questionnaires, (4) are disqualified at the discretion of the treating physician, and/or (4) live beyond a 75 mile radius of the hospital.

Sponsors & Collaborators

• West Virginia University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

WVU Mary Babb Randolph Cancer Center and Ruby Hospital

Morgantown, West Virginia, 26506, United States

Location

Related Publications (3)

• Chen YJ, Narsavage GL, Culp SL, Weaver TE. The development and psychometric analysis of the short-form Pulmonary Functional Status Scale (PFSS-11). Res Nurs Health. 2010 Dec;33(6):477-85. doi: 10.1002/nur.20403. Epub 2010 Oct 18.

  PMID: 20957666 BACKGROUND

• Narsavage G, Romeo E. Education and support needs of younger and older cancer survivors. Appl Nurs Res. 2003 May;16(2):103-9. doi: 10.1016/s0897-1897(03)00008-9.

  PMID: 12764721 BACKGROUND

• Narsavage GL, Naylor MD. Factors associated with referral of elderly individuals with cardiac and pulmonary disorders for home care services following hospital discharge. J Gerontol Nurs. 2000 May;26(5):14-20. doi: 10.3928/0098-9134-20000501-08.

  PMID: 11111516 BACKGROUND

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Georgia L Narsavage
• Organization: West Virginia University

gnarsavage@hsc.wvu.edu

304-293-6729

Study Officials

• Georgia L Narsavage, PhD, MSN

  West Virginia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2012
• First Posted: August 22, 2012
• Study Start: April 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: June 1, 2013
• Last Updated: October 18, 2022
• Results First Posted: January 20, 2022

Record last verified: 2021-12

Locations

US (1)