Trial Outcomes & Findings for Depression and Congestive Heart Failure in Outpatients. (NCT NCT00321269)
NCT ID: NCT00321269
Last Updated: 2015-12-24
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
134 participants
Primary outcome timeframe
Depression and psychological health will be assessed at week 1, week 8
Results posted on
2015-12-24
Participant Flow
Participant milestones
| Measure |
8-week Phone Based Single Illness Management
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
|
8-week Phone Based Comorbid Illness Management
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 Study
STARTED
|
74
|
74
|
|
Overall Study
COMPLETED
|
66
|
68
|
|
Overall Study
NOT COMPLETED
|
8
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Depression and Congestive Heart Failure in Outpatients.
Baseline characteristics by cohort
| Measure |
8-week Phone Based Single Illness Management
n=66 Participants
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
|
8-Week Phone-based Comorbid Illness Management
n=68 Participants
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
n=134 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
72.4 years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
67.8 years
STANDARD_DEVIATION 9.1 • n=7 Participants
|
70.1 years
STANDARD_DEVIATION 9.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
65 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
131 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
66 participants
n=5 Participants
|
68 participants
n=7 Participants
|
134 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Depression and psychological health will be assessed at week 1, week 8Population: Older Veterans with Heart Failure
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.
Outcome measures
| Measure |
8-week Phone-based Single Illness Management
n=66 Participants
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
|
8-week Phone-based Comorbid Illness Management
n=68 Participants
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
|
|---|---|---|
|
Beck Depression Inventory II
Week 1
|
9.3 units on a scale
Standard Deviation 0.85
|
9.2 units on a scale
Standard Deviation 0.84
|
|
Beck Depression Inventory II
Week 8
|
9.0 units on a scale
Standard Deviation 0.95
|
8.6 units on a scale
Standard Deviation 0.96
|
SECONDARY outcome
Timeframe: Measured at week 1, week 8Population: Older Veterans with Congestive Heart Failure
Medical Outcomes Study SF-36 Physical Function Subscale- 10 Items Range 0 to 100, Higher Scores indicate higher functioning.
Outcome measures
| Measure |
8-week Phone-based Single Illness Management
n=66 Participants
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
|
8-week Phone-based Comorbid Illness Management
n=68 Participants
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
|
|---|---|---|
|
Health-Related Quality of Life
Week 1
|
36.82 units on a scale
Standard Deviation 2.7
|
37.2 units on a scale
Standard Deviation 2.7
|
|
Health-Related Quality of Life
Week 8
|
36.5 units on a scale
Standard Deviation 2.9
|
43.1 units on a scale
Standard Deviation 2.9
|
Adverse Events
8-week Telephone Based Single Illness Management
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
8-Week Phone Based Comorbid Illness Management
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
8-week Telephone Based Single Illness Management
n=66 participants at risk
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
|
8-Week Phone Based Comorbid Illness Management
n=68 participants at risk
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
|
|---|---|---|
|
Psychiatric disorders
Suicide
|
0.00%
0/66 • 8 weeks- duration of the clinical trial. Adverse event was assessed at Week 4 and Week 8.
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).
|
0.00%
0/68 • 8 weeks- duration of the clinical trial. Adverse event was assessed at Week 4 and Week 8.
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).
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place