Trial Outcomes & Findings for Home Telemonitoring for Patients With Lung Cancer (NCT NCT01670539)
NCT ID: NCT01670539
Last Updated: 2022-10-18
Results Overview
Changes in temperature measured by telemonitor daily over 14 days after hospital discharge
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
47 participants
Primary outcome timeframe
14 days
Results posted on
2022-10-18
Participant Flow
Subjects were enrolled from West Virginia University Ruby Memorial Hospital (WVUH) and the Mary Babb Randolph Cancer Center (MBRCC) at WVUH. The study subject recruitment began in April, 2011 and terminated at the end of December 2012.
Two visits were needed in hospital to explain study prior to requesting consent in order to address literacy and provide opportunity for family member to be present. Time 1 data were collected at time of consent and then patients were assigned to groups prior to discharge.
Participant milestones
| Measure |
Telemonitor
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.
HomMed Telemonitor: 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).
|
Routine Care for Patients With lungCa
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.
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
21
|
|
Overall Study
COMPLETED
|
20
|
16
|
|
Overall Study
NOT COMPLETED
|
6
|
5
|
Reasons for withdrawal
| Measure |
Telemonitor
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.
HomMed Telemonitor: 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).
|
Routine Care for Patients With lungCa
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.
|
|---|---|---|
|
Overall Study
Death
|
3
|
5
|
|
Overall Study
Withdrawal by Subject
|
3
|
0
|
Baseline Characteristics
All efforts have been made to contact the PI, but the only available information is a small results document. The results information found was not always broken down by arm and the gender and race information provided include information from a 10 person sub-study. It cannot be determined which participants were from the sub-study, so information related to gender and race for this specific study cannot be determined.
Baseline characteristics by cohort
| Measure |
Telemonitor and Routine Care for Patients With lungCa
n=47 Participants
PI left the institution and demographic information was not broken down into arms.
Telemonitor:
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.
HomMed Telemonitor: 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).
Routine care for patients with lungCa:
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.
|
|---|---|
|
Age, Continuous
|
63 years
STANDARD_DEVIATION 9.9 • n=47 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
All efforts have been made to contact the PI, but the only available information is a small results document. The results information found was not always broken down by arm and the gender and race information provided include information from a 10 person sub-study. It cannot be determined which participants were from the sub-study, so information related to gender and race for this specific study cannot be determined.
|
|
Sex: Female, Male
Male
|
0 Participants
All efforts have been made to contact the PI, but the only available information is a small results document. The results information found was not always broken down by arm and the gender and race information provided include information from a 10 person sub-study. It cannot be determined which participants were from the sub-study, so information related to gender and race for this specific study cannot be determined.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=47 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=47 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=47 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=47 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=47 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=47 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
47 Participants
n=47 Participants
|
PRIMARY outcome
Timeframe: 14 daysPopulation: Results information was not available broken down by arm.
Changes in temperature measured by telemonitor daily over 14 days after hospital discharge
Outcome measures
| Measure |
Telemonitor and Routine Care for Patients With lungCa
n=47 Participants
PI left the institution and demographic information was not broken down into arms.
Telemonitor:
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.
HomMed Telemonitor: 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).
Routine care for patients with lungCa:
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.
|
Routine Care for Patients With lungCa
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.
|
|---|---|---|
|
Changes in Telemonitor Data From Baseline: Temperature
|
97.05 Degrees Fahrenheit
Interval 96.6 to 97.5
|
—
|
PRIMARY outcome
Timeframe: 14 daysPopulation: Results information was not available broken down by arm
Changes in pulse rate measured by telemonitor daily over 14 days after hospital discharge
Outcome measures
| Measure |
Telemonitor and Routine Care for Patients With lungCa
n=47 Participants
PI left the institution and demographic information was not broken down into arms.
Telemonitor:
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.
HomMed Telemonitor: 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).
Routine care for patients with lungCa:
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.
|
Routine Care for Patients With lungCa
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.
|
|---|---|---|
|
Changes in Telemonitor Data From Baseline: Pulse Rate
|
93 beats per minutes (bpm)
Interval 89.0 to 97.0
|
—
|
PRIMARY outcome
Timeframe: 14 daysPopulation: Results information was not available broken down by arm
Changes in blood pressure measured by telemonitor daily over 14 days after hospital discharge
Outcome measures
| Measure |
Telemonitor and Routine Care for Patients With lungCa
n=47 Participants
PI left the institution and demographic information was not broken down into arms.
Telemonitor:
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.
HomMed Telemonitor: 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).
Routine care for patients with lungCa:
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.
|
Routine Care for Patients With lungCa
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.
|
|---|---|---|
|
Changes in Telemonitor Data From Baseline: Blood Pressure
Diastolic
|
69.5 mmHg
Interval 66.0 to 73.0
|
—
|
|
Changes in Telemonitor Data From Baseline: Blood Pressure
Systolic
|
122 mmHg
Interval 115.0 to 129.0
|
—
|
PRIMARY outcome
Timeframe: 14 daysPopulation: Results information was not available broken down by arm.
Changes in SpO2 measured by telemonitor daily over 14 days after hospital discharge
Outcome measures
| Measure |
Telemonitor and Routine Care for Patients With lungCa
n=47 Participants
PI left the institution and demographic information was not broken down into arms.
Telemonitor:
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.
HomMed Telemonitor: 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).
Routine care for patients with lungCa:
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.
|
Routine Care for Patients With lungCa
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.
|
|---|---|---|
|
Changes in Telemonitor Data From Baseline: SpO2
|
93.5 percentage of oxygen
Interval 92.0 to 95.0
|
—
|
PRIMARY outcome
Timeframe: 14 daysPopulation: Results information was not available broken down by arm.
Changes in weight measured by telemonitor daily over 14 days after hospital discharge
Outcome measures
| Measure |
Telemonitor and Routine Care for Patients With lungCa
n=47 Participants
PI left the institution and demographic information was not broken down into arms.
Telemonitor:
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.
HomMed Telemonitor: 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).
Routine care for patients with lungCa:
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.
|
Routine Care for Patients With lungCa
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.
|
|---|---|---|
|
Changes in Telemonitor Data From Baseline: Weight
|
161.5 pounds
Interval 155.0 to 168.0
|
—
|
SECONDARY outcome
Timeframe: 14 daysNumeric rating for dyspnea, from 0 to 10 with a lower number being a decrease in dysnea. Symptom data requiring yes-no answers to whether the symptom is worse today than yesterday : dyspnea are collected daily via telemonitor for 14 days.
Outcome measures
| Measure |
Telemonitor and Routine Care for Patients With lungCa
n=26 Participants
PI left the institution and demographic information was not broken down into arms.
Telemonitor:
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.
HomMed Telemonitor: 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).
Routine care for patients with lungCa:
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.
|
Routine Care for Patients With lungCa
n=21 Participants
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.
|
|---|---|---|
|
Changes in Telemonitor Symptoms Recorded From Baseline: Dyspnea
|
3.8 score on a scale
Interval 3.7 to 3.8
|
2 score on a scale
Interval 2.0 to 3.1
|
SECONDARY outcome
Timeframe: 14 daysPulmonary Functional Status Scale (PFSS-11) , scoring from 0 to 10 with increasing scores indicating an improvement in functioning. Symptom data requiring yes-no answers to whether the symptom is worse today than yesterday : general functioning activities, are collected daily via telemonitor for 14 days.
Outcome measures
| Measure |
Telemonitor and Routine Care for Patients With lungCa
n=26 Participants
PI left the institution and demographic information was not broken down into arms.
Telemonitor:
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.
HomMed Telemonitor: 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).
Routine care for patients with lungCa:
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.
|
Routine Care for Patients With lungCa
n=21 Participants
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.
|
|---|---|---|
|
Changes in Telemonitor Symptoms Recorded From Baseline: Functioning
|
3.6 score on a scale
Interval 2.8 to 3.6
|
3.2 score on a scale
Interval 3.1 to 3.2
|
SECONDARY outcome
Timeframe: 14 daysNumeric rating for pain (0 to 10 scale) with a lower number indicating less pain. Symptom data requiring yes-no answers to whether the symptom is worse today than yesterday : pain are collected daily via telemonitor for 14 days.
Outcome measures
| Measure |
Telemonitor and Routine Care for Patients With lungCa
n=26 Participants
PI left the institution and demographic information was not broken down into arms.
Telemonitor:
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.
HomMed Telemonitor: 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).
Routine care for patients with lungCa:
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.
|
Routine Care for Patients With lungCa
n=21 Participants
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.
|
|---|---|---|
|
Changes in Telemonitor Symptoms Recorded From Baseline: Pain
|
2.8 score on a scale
Interval 2.8 to 4.0
|
2.8 score on a scale
Interval 2.8 to 3.0
|
Adverse Events
Telemonitor
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Routine Care for Patients With lungCa
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place