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Trial record 35 of 229 for:    "Depressive Disorder" [DISEASE] | ( Map: Missouri, United States )

Depression and Congestive Heart Failure in Outpatients.

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ClinicalTrials.gov Identifier: NCT00321269
Recruitment Status : Completed
First Posted : May 3, 2006
Results First Posted : October 21, 2015
Last Update Posted : December 24, 2015
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor)
Conditions Heart Failure
Depression
Interventions Behavioral: Single Illness Management
Behavioral: Comorbid Illness Management
Enrollment 134
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 8-week Phone Based Single Illness Management 8-week Phone Based Comorbid Illness Management
Hide Arm/Group Description

Standard nursing intervention to treat Congestive Heart Failure

Education & behavioral techniques to help CHF patients cope with chronic illness: 8 week nursing intervention addressing Congestive Heart Failure

Nursing intervention to treat Congestive Heart Failure and emotional coping

CHF and emotional coping: 8 week nursing intervention to address Congestive Heart Failure and emotional coping

Period Title: Overall Study
Started 74 74
Completed 66 68
Not Completed 8 6
Arm/Group Title 8-week Phone Based Single Illness Management 8-Week Phone-based Comorbid Illness Management Total
Hide Arm/Group Description

Standard nursing intervention to treat Congestive Heart Failure

Education & behavioral techniques to help CHF patients cope with chronic illness: 8 week nursing intervention addressing Congestive Heart Failure

Nursing intervention to treat Congestive Heart Failure and emotional coping

CHF and emotional coping: 8 week nursing intervention to address Congestive Heart Failure and emotional coping

Total of all reporting groups
Overall Number of Baseline Participants 66 68 134
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 66 participants 68 participants 134 participants
72.4  (8.9) 67.8  (9.1) 70.1  (9.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 66 participants 68 participants 134 participants
Female
1
   1.5%
2
   2.9%
3
   2.2%
Male
65
  98.5%
66
  97.1%
131
  97.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 66 participants 68 participants 134 participants
66 68 134
1.Primary Outcome
Title Beck Depression Inventory II
Hide Description Depressive Symptoms measured on a Beck Depression Inventory Revised Possible Range 0 to 63. Higher scores indicate greater depression. Effectiveness of treatment indicated by a decline in the BDI-II score.
Time Frame Depression and psychological health will be assessed at week 1, week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Older Veterans with Heart Failure
Arm/Group Title 8-week Phone-based Single Illness Management 8-week Phone-based Comorbid Illness Management
Hide Arm/Group Description:

Standard nursing intervention to treat Congestive Heart Failure

Education & behavioral techniques to help CHF patients cope with chronic illness: 8 week nursing intervention addressing Congestive Heart Failure

Nursing intervention to treat Congestive Heart Failure and emotional coping

CHF and emotional coping: 8 week nursing intervention to address Congestive Heart Failure and emotional coping

Overall Number of Participants Analyzed 66 68
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 1 9.3  (0.85) 9.2  (0.84)
Week 8 9.0  (0.95) 8.6  (0.96)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 8-week Phone-based Single Illness Management, 8-week Phone-based Comorbid Illness Management
Comments Mixed effects regression analysis- Treatment Arm X Time F (2, 116)=0.09, P>F=0.90.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.90
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
2.Secondary Outcome
Title Health-Related Quality of Life
Hide Description Medical Outcomes Study SF-36 Physical Function Subscale- 10 Items Range 0 to 100, Higher Scores indicate higher functioning.
Time Frame Measured at week 1, week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Older Veterans with Congestive Heart Failure
Arm/Group Title 8-Week Phone-Based Single Illness Management 8-Week Phone-Based Comorbid Illness Management
Hide Arm/Group Description:

Standard nursing intervention to treat Congestive Heart Failure

Education & behavioral techniques to help CHF patients cope with chronic illness: 8 week nursing intervention addressing Congestive Heart Failure

Nursing intervention to treat Congestive Heart Failure and emotional coping

CHF and emotional coping: 8 week nursing intervention to address Congestive Heart Failure and emotional coping

Overall Number of Participants Analyzed 66 68
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 1 36.82  (2.7) 37.2  (2.7)
Week 8 36.5  (2.9) 43.1  (2.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 8-Week Phone-Based Single Illness Management, 8-Week Phone-Based Comorbid Illness Management
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.13
Comments [Not Specified]
Method Mixed Models Analysis
Comments F(2,110)=2.08; P=0.13
Time Frame 8 weeks- duration of the clinical trial. Adverse event was assessed at Week 4 and Week 8.
Adverse Event Reporting Description

Participants indicating depression were assessed for suicidality and any mortality due to suicide was monitored. These were the only adverse events monitored specifically.

Suicidal ideation was assessed using the Beck Depression Inventory (Question #9) and the Structured Clinical Interview for DSM (Suicidal ideation question).

 
Arm/Group Title 8-week Telephone Based Single Illness Management 8-Week Phone Based Comorbid Illness Management
Hide Arm/Group Description

Standard nursing intervention to treat Congestive Heart Failure

Education & behavioral techniques to help CHF patients cope with chronic illness: 8 week nursing intervention addressing Congestive Heart Failure

Nursing intervention to treat Congestive Heart Failure and emotional coping

CHF and emotional coping: 8 week nursing intervention to address Congestive Heart Failure and emotional coping

All-Cause Mortality
8-week Telephone Based Single Illness Management 8-Week Phone Based Comorbid Illness Management
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
8-week Telephone Based Single Illness Management 8-Week Phone Based Comorbid Illness Management
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/66 (0.00%)      0/68 (0.00%)    
Psychiatric disorders     
Suicide   0/66 (0.00%)  0 0/68 (0.00%)  0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
8-week Telephone Based Single Illness Management 8-Week Phone Based Comorbid Illness Management
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/66 (0.00%)      0/68 (0.00%)    
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: Carolyn Turvey
Organization: Iowa City VA Health Care System
Phone: 319 338 0581 ext 7714
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00321269     History of Changes
Other Study ID Numbers: IIR 06-082
First Submitted: May 1, 2006
First Posted: May 3, 2006
Results First Submitted: November 12, 2014
Results First Posted: October 21, 2015
Last Update Posted: December 24, 2015