We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

The ACTIVE Intervention to Improve Hospice Care

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01211340
First Posted: September 29, 2010
Last Update Posted: June 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Debra Parker Oliver, PhD, MSW, University of Missouri-Columbia
Results First Submitted: September 2, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Condition: Pain
Intervention: Behavioral: ACTIVE

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Usual Care This arm serves as the control, individuals will not receive the intervention but will receive all measures
Intervention Arm

These caregivers will receive usual care plus the technology which allows them to participate in their plan of care meeting

ACTIVE: Assessing Caregivers for Team Intervention via Video Encounters: this intervention uses video technology to bridge geographic distance to empower hospice caregivers to participate in plan of care meetings for their patient


Participant Flow:   Overall Study
    Usual Care   Intervention Arm
STARTED   223   223 
COMPLETED   223   223 
NOT COMPLETED   0   0 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Usual Care This arm serves as the control, individuals will not receive the intervention but will receive all measures
Intervention Arm

These caregivers will receive usual care plus the technology which allows them to participate in their plan of care meeting

ACTIVE: Assessing Caregivers for Team Intervention via Video Encounters: this intervention uses video technology to bridge geographic distance to empower hospice caregivers to participate in plan of care meetings for their patient

Total Total of all reporting groups

Baseline Measures
   Usual Care   Intervention Arm   Total 
Overall Participants Analyzed 
[Units: Participants]
 223   223   446 
Age 
[Units: Years]
Mean (Standard Deviation)
 59.2  (13.3)   60.1  (12.5)   59.7  (12.9) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      182  81.6%      168  75.3%      350  78.5% 
Male      41  18.4%      55  24.7%      96  21.5% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      2   0.9%      3   1.3%      5   1.1% 
Not Hispanic or Latino      221  99.1%      220  98.7%      441  98.9% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      2   0.9%      7   3.1%      9   2.0% 
Asian      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      13   5.8%      10   4.5%      23   5.2% 
White      205  91.9%      204  91.5%      409  91.7% 
More than one race      1   0.4%      1   0.4%      2   0.4% 
Unknown or Not Reported      2   0.9%      1   0.4%      3   0.7% 
Region of Enrollment 
[Units: Participants]
     
United States   223   223   446 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Caregiver Perceptions of Pain Medicine Questionaire   [ Time Frame: Every 14 days until the death of the patient for an average of 45 days-Only measure used in analysis is the last completed measure ]

2.  Secondary:   Caregiver Quality of Life-Revised Subscale Emotional   [ Time Frame: Every 14 days until the death of the patient for an average of 45 days-Only measure used in analysis is the last completed measure ]

3.  Secondary:   Anxiety   [ Time Frame: Every 14 days until the death of the patient for an average of 45 days-Only measure used in analysis is the last completed measure ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Debra Parker Oliver
Organization: University of Missouri
phone: 573-884-5301
e-mail: oliverdr@missouri.health.edu


Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):


Responsible Party: Debra Parker Oliver, PhD, MSW, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT01211340     History of Changes
Other Study ID Numbers: 1160518
First Submitted: September 23, 2010
First Posted: September 29, 2010
Results First Submitted: September 2, 2015
Results First Posted: June 20, 2017
Last Update Posted: June 20, 2017



To Top