Trial Outcomes & Findings for Hospice Problem Solving Intervention (NCT NCT01444027)
NCT ID: NCT01444027
Last Updated: 2017-12-13
Results Overview
Caregiver anxiety was measured with the 7-item Generalized Anxiety Disorder (GAD-7) Scale (Spitzer et al., 2006), which measures the frequency with which respondents experience symptoms of anxiety such as restlessness, difficulty relaxing, and uncontrollable worrying. The GAD-7 total scores range from 0 to 21, with higher scores indicating more anxiety.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
514 participants
Primary outcome timeframe
At Baseline and Exit (approximately 4 weeks after recruitment)
Results posted on
2017-12-13
Participant Flow
Participant milestones
| Measure |
Attention Control
This group receives standard care with the attention of social support/ "friendly interactions" and serves as an attention control group.
|
Intervention Group 1 (Face to Face)
This group receives Problem Solving Therapy in face to face visits.
Problem Solving Therapy: Problem-solving therapy (PST) focuses on behavioral change principles derived from this theoretical framework. PST addresses four skills: 1) problem definition and formulation, which involves gathering data and information, articulating the issue in clear terms, identifying the challenge, and setting realistic goals; 2) generation of alternative strategies; 3) decision making; and 4) solution implementation. The intervention is delivered in a series of interactions with the interventionist.
|
Intervention Group 2 (Video)
This group receives Problem Solving Therapy via video.
Problem Solving Therapy: Problem-solving therapy (PST) focuses on behavioral change principles derived from this theoretical framework. PST addresses four skills: 1) problem definition and formulation, which involves gathering data and information, articulating the issue in clear terms, identifying the challenge, and setting realistic goals; 2) generation of alternative strategies; 3) decision making; and 4) solution implementation. The intervention is delivered in a series of interactions with the interventionist.
|
|---|---|---|---|
|
Overall Study
STARTED
|
172
|
171
|
171
|
|
Overall Study
Received Intervention as Assigned
|
168
|
161
|
147
|
|
Overall Study
1 Month Follow-up
|
160
|
159
|
141
|
|
Overall Study
3 Month Follow-up
|
142
|
141
|
133
|
|
Overall Study
COMPLETED
|
142
|
141
|
133
|
|
Overall Study
NOT COMPLETED
|
30
|
30
|
38
|
Reasons for withdrawal
| Measure |
Attention Control
This group receives standard care with the attention of social support/ "friendly interactions" and serves as an attention control group.
|
Intervention Group 1 (Face to Face)
This group receives Problem Solving Therapy in face to face visits.
Problem Solving Therapy: Problem-solving therapy (PST) focuses on behavioral change principles derived from this theoretical framework. PST addresses four skills: 1) problem definition and formulation, which involves gathering data and information, articulating the issue in clear terms, identifying the challenge, and setting realistic goals; 2) generation of alternative strategies; 3) decision making; and 4) solution implementation. The intervention is delivered in a series of interactions with the interventionist.
|
Intervention Group 2 (Video)
This group receives Problem Solving Therapy via video.
Problem Solving Therapy: Problem-solving therapy (PST) focuses on behavioral change principles derived from this theoretical framework. PST addresses four skills: 1) problem definition and formulation, which involves gathering data and information, articulating the issue in clear terms, identifying the challenge, and setting realistic goals; 2) generation of alternative strategies; 3) decision making; and 4) solution implementation. The intervention is delivered in a series of interactions with the interventionist.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
10
|
24
|
|
Overall Study
Lost to Follow-up
|
26
|
20
|
14
|
Baseline Characteristics
Hospice Problem Solving Intervention
Baseline characteristics by cohort
| Measure |
Attention Control
n=172 Participants
This group receives standard care with the attention of social support/ "friendly interactions" and serves as an attention control group.
|
Intervention Group 1 (Face to Face)
n=171 Participants
This group receives Problem Solving Therapy in face to face visits.
Problem Solving Therapy: Problem-solving therapy (PST) focuses on behavioral change principles derived from this theoretical framework. PST addresses four skills: 1) problem definition and formulation, which involves gathering data and information, articulating the issue in clear terms, identifying the challenge, and setting realistic goals; 2) generation of alternative strategies; 3) decision making; and 4) solution implementation. The intervention is delivered in a series of interactions with the interventionist.
|
Intervention Group 2 (Video)
n=171 Participants
This group receives Problem Solving Therapy via video.
Problem Solving Therapy: Problem-solving therapy (PST) focuses on behavioral change principles derived from this theoretical framework. PST addresses four skills: 1) problem definition and formulation, which involves gathering data and information, articulating the issue in clear terms, identifying the challenge, and setting realistic goals; 2) generation of alternative strategies; 3) decision making; and 4) solution implementation. The intervention is delivered in a series of interactions with the interventionist.
|
Total
n=514 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
59.7 years
STANDARD_DEVIATION 13.6 • n=5 Participants
|
59.9 years
STANDARD_DEVIATION 11.6 • n=7 Participants
|
61.3 years
STANDARD_DEVIATION 12.0 • n=5 Participants
|
60.3 years
STANDARD_DEVIATION 12.4 • n=4 Participants
|
|
Sex: Female, Male
Female
|
132 Participants
n=5 Participants
|
125 Participants
n=7 Participants
|
129 Participants
n=5 Participants
|
386 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
128 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
155 Participants
n=5 Participants
|
153 Participants
n=7 Participants
|
152 Participants
n=5 Participants
|
460 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
172 Participants
n=5 Participants
|
171 Participants
n=7 Participants
|
171 Participants
n=5 Participants
|
514 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: At Baseline and Exit (approximately 4 weeks after recruitment)Population: Intent to treat population (all participants who received at least one intervention session). Multiple imputation was used to replace missing data.
Caregiver anxiety was measured with the 7-item Generalized Anxiety Disorder (GAD-7) Scale (Spitzer et al., 2006), which measures the frequency with which respondents experience symptoms of anxiety such as restlessness, difficulty relaxing, and uncontrollable worrying. The GAD-7 total scores range from 0 to 21, with higher scores indicating more anxiety.
Outcome measures
| Measure |
Attention Control
n=172 Participants
This group receives standard care with the attention of social support/ "friendly interactions" and serves as an attention control group.
|
Intervention Group 1 (Face to Face)
n=171 Participants
This group receives Problem Solving Therapy in face to face visits.
Problem Solving Therapy: Problem-solving therapy (PST) focuses on behavioral change principles derived from this theoretical framework. PST addresses four skills: 1) problem definition and formulation, which involves gathering data and information, articulating the issue in clear terms, identifying the challenge, and setting realistic goals; 2) generation of alternative strategies; 3) decision making; and 4) solution implementation. The intervention is delivered in a series of interactions with the interventionist.
|
Intervention Group 2 (Video)
n=171 Participants
This group receives Problem Solving Therapy via video.
Problem Solving Therapy: Problem-solving therapy (PST) focuses on behavioral change principles derived from this theoretical framework. PST addresses four skills: 1) problem definition and formulation, which involves gathering data and information, articulating the issue in clear terms, identifying the challenge, and setting realistic goals; 2) generation of alternative strategies; 3) decision making; and 4) solution implementation. The intervention is delivered in a series of interactions with the interventionist.
|
|---|---|---|---|
|
Caregiver Anxiety: Change From Baseline to Post-Intervention Exit
|
-0.9 units on a scale
Standard Error 0.3
|
-2.0 units on a scale
Standard Error 0.4
|
-0.7 units on a scale
Standard Error 0.4
|
PRIMARY outcome
Timeframe: At Baseline and Exit (approximately 4 weeks after recruitment)Population: Intent to treat population (all participants who received at least one intervention session). Multiple imputation was used to replace missing data.
An interview CQLI version was developed by using identical items from the paper-based CQLI and replacing the visual analogue response format with a 0-10 response scale. Higher scores indicate better physical quality of life.
Outcome measures
| Measure |
Attention Control
n=172 Participants
This group receives standard care with the attention of social support/ "friendly interactions" and serves as an attention control group.
|
Intervention Group 1 (Face to Face)
n=171 Participants
This group receives Problem Solving Therapy in face to face visits.
Problem Solving Therapy: Problem-solving therapy (PST) focuses on behavioral change principles derived from this theoretical framework. PST addresses four skills: 1) problem definition and formulation, which involves gathering data and information, articulating the issue in clear terms, identifying the challenge, and setting realistic goals; 2) generation of alternative strategies; 3) decision making; and 4) solution implementation. The intervention is delivered in a series of interactions with the interventionist.
|
Intervention Group 2 (Video)
n=171 Participants
This group receives Problem Solving Therapy via video.
Problem Solving Therapy: Problem-solving therapy (PST) focuses on behavioral change principles derived from this theoretical framework. PST addresses four skills: 1) problem definition and formulation, which involves gathering data and information, articulating the issue in clear terms, identifying the challenge, and setting realistic goals; 2) generation of alternative strategies; 3) decision making; and 4) solution implementation. The intervention is delivered in a series of interactions with the interventionist.
|
|---|---|---|---|
|
Caregiver Quality of Life - Physical: Change From Baseline to Post-Intervention Exit
|
-0.4 units on a scale
Standard Error 0.1
|
0.2 units on a scale
Standard Error 0.1
|
-0.2 units on a scale
Standard Error 0.1
|
PRIMARY outcome
Timeframe: At Baseline and Exit (approximately 4 weeks after recruitment)Population: Intent to treat population (all participants who received at least one intervention session). Multiple imputation was used to replace missing data.
An interview CQLI version was developed by using identical items from the paper-based CQLI and replacing the visual analogue response format with a 0-10 response scale. Higher scores indicate better social quality of life.
Outcome measures
| Measure |
Attention Control
n=172 Participants
This group receives standard care with the attention of social support/ "friendly interactions" and serves as an attention control group.
|
Intervention Group 1 (Face to Face)
n=171 Participants
This group receives Problem Solving Therapy in face to face visits.
Problem Solving Therapy: Problem-solving therapy (PST) focuses on behavioral change principles derived from this theoretical framework. PST addresses four skills: 1) problem definition and formulation, which involves gathering data and information, articulating the issue in clear terms, identifying the challenge, and setting realistic goals; 2) generation of alternative strategies; 3) decision making; and 4) solution implementation. The intervention is delivered in a series of interactions with the interventionist.
|
Intervention Group 2 (Video)
n=171 Participants
This group receives Problem Solving Therapy via video.
Problem Solving Therapy: Problem-solving therapy (PST) focuses on behavioral change principles derived from this theoretical framework. PST addresses four skills: 1) problem definition and formulation, which involves gathering data and information, articulating the issue in clear terms, identifying the challenge, and setting realistic goals; 2) generation of alternative strategies; 3) decision making; and 4) solution implementation. The intervention is delivered in a series of interactions with the interventionist.
|
|---|---|---|---|
|
Caregiver Quality of Life - Social: Change From Baseline to Post-Intervention Exit
|
-0.2 units on a scale
Standard Error 0.2
|
0.2 units on a scale
Standard Error 0.1
|
-0.4 units on a scale
Standard Error 0.2
|
PRIMARY outcome
Timeframe: At Baseline and Exit (approximately 4 weeks after recruitment)Population: Intent to treat population (all participants who received at least one intervention session). Multiple imputation was used to replace missing data.
An interview CQLI version was developed by using identical items from the paper-based CQLI and replacing the visual analogue response format with a 0-10 response scale. Higher scores indicate better emotional quality of life.
Outcome measures
| Measure |
Attention Control
n=172 Participants
This group receives standard care with the attention of social support/ "friendly interactions" and serves as an attention control group.
|
Intervention Group 1 (Face to Face)
n=171 Participants
This group receives Problem Solving Therapy in face to face visits.
Problem Solving Therapy: Problem-solving therapy (PST) focuses on behavioral change principles derived from this theoretical framework. PST addresses four skills: 1) problem definition and formulation, which involves gathering data and information, articulating the issue in clear terms, identifying the challenge, and setting realistic goals; 2) generation of alternative strategies; 3) decision making; and 4) solution implementation. The intervention is delivered in a series of interactions with the interventionist.
|
Intervention Group 2 (Video)
n=171 Participants
This group receives Problem Solving Therapy via video.
Problem Solving Therapy: Problem-solving therapy (PST) focuses on behavioral change principles derived from this theoretical framework. PST addresses four skills: 1) problem definition and formulation, which involves gathering data and information, articulating the issue in clear terms, identifying the challenge, and setting realistic goals; 2) generation of alternative strategies; 3) decision making; and 4) solution implementation. The intervention is delivered in a series of interactions with the interventionist.
|
|---|---|---|---|
|
Caregiver Quality of Life - Emotional: Change From Baseline to Post-Intervention Exit
|
-0.1 units on a scale
Standard Error 0.2
|
0.4 units on a scale
Standard Error 0.1
|
0.0 units on a scale
Standard Error 0.2
|
PRIMARY outcome
Timeframe: At Baseline and Exit (approximately 4 weeks after recruitment)Population: Intent to treat population (all participants who received at least one intervention session). Multiple imputation was used to replace missing data.
An interview CQLI version was developed by using identical items from the paper-based CQLI and replacing the visual analogue response format with a 0-10 response scale. Higher scores indicate better financial quality of life.
Outcome measures
| Measure |
Attention Control
n=172 Participants
This group receives standard care with the attention of social support/ "friendly interactions" and serves as an attention control group.
|
Intervention Group 1 (Face to Face)
n=171 Participants
This group receives Problem Solving Therapy in face to face visits.
Problem Solving Therapy: Problem-solving therapy (PST) focuses on behavioral change principles derived from this theoretical framework. PST addresses four skills: 1) problem definition and formulation, which involves gathering data and information, articulating the issue in clear terms, identifying the challenge, and setting realistic goals; 2) generation of alternative strategies; 3) decision making; and 4) solution implementation. The intervention is delivered in a series of interactions with the interventionist.
|
Intervention Group 2 (Video)
n=171 Participants
This group receives Problem Solving Therapy via video.
Problem Solving Therapy: Problem-solving therapy (PST) focuses on behavioral change principles derived from this theoretical framework. PST addresses four skills: 1) problem definition and formulation, which involves gathering data and information, articulating the issue in clear terms, identifying the challenge, and setting realistic goals; 2) generation of alternative strategies; 3) decision making; and 4) solution implementation. The intervention is delivered in a series of interactions with the interventionist.
|
|---|---|---|---|
|
Caregiver Quality of Life - Financial: Change From Baseline to Post-Intervention Exit
|
0.0 units on a scale
Standard Error 0.1
|
0.5 units on a scale
Standard Error 0.1
|
0.0 units on a scale
Standard Error 0.2
|
Adverse Events
Attention Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intervention Group 1 (Face to Face)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intervention Group 2 (Video)
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
Dr. George Demiris
University of Washington, School of Nursing
Phone: 206-221-3866
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place