Hospice Informal Caregivers
Conditions
Brief summary
In recent years, the demand for home hospice care has grown rapidly. Family members and friends who act as informal caregivers are essential to the provision of palliative care services; however, this role is not without adverse effects on the caregivers themselves. It is well documented that emotional needs of individuals caring for dying persons in their home are not well attended, and interventions aiming to provide support to informal hospice caregivers are notably lacking. In this context, problem solving therapy (PST) provides an overall coping process that fosters adaptive situational coping and behavioral competence. The investigators are conducting a randomized controlled trial to fully evaluate the PST intervention for informal hospice caregivers. Additionally, the investigators aim to evaluate how the modality of the intervention (face to face vs video) impacts its effectiveness. This investigator team is conducting a 4-year randomized trial study in which hospice caregivers will be randomly assigned to a group receiving standard hospice care with the addition of social support interactions (attention control group) or a group receiving standard hospice care with the addition of the problem solving intervention delivered face to face (intervention group 1) or a group receiving standard hospice care with the addition of the problem solving intervention delivered via video (intervention group 2). The specific aims include an assessment of the impact of PST on caregiver quality of life, problem solving ability, and caregiver anxiety.
Interventions
BEHAVIORALProblem 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.
Sponsors
National Institute of Nursing Research (NINR)
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* enrolled as a family/informal caregiver of a hospice patient * 18 years or older * with access to a standard phone line or Internet and computer access at home * without functional hearing loss or with a hearing aid that allows the participant to conduct telephone conversations as assessed by the research staff (by questioning and observing the caregiver) * no or only mild cognitive impairment * speak and read English, with at least a 6th-grade education
Exclusion criteria
* lack of phone or Internet access
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Caregiver Anxiety: Change From Baseline to Post-Intervention Exit | At Baseline and Exit (approximately 4 weeks after recruitment) | 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. |
| Caregiver Quality of Life - Physical: Change From Baseline to Post-Intervention Exit | At Baseline and Exit (approximately 4 weeks after recruitment) | 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. |
| Caregiver Quality of Life - Social: Change From Baseline to Post-Intervention Exit | At Baseline and Exit (approximately 4 weeks after recruitment) | 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. |
| Caregiver Quality of Life - Emotional: Change From Baseline to Post-Intervention Exit | At Baseline and Exit (approximately 4 weeks after recruitment) | 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. |
| Caregiver Quality of Life - Financial: Change From Baseline to Post-Intervention Exit | At Baseline and Exit (approximately 4 weeks after recruitment) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Attention Control This group receives standard care with the attention of social support/ friendly interactions and serves as an attention control group. | 172 |
| 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. | 171 |
| 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. | 171 |
| Total | 514 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 26 | 20 | 14 |
| Overall Study | Withdrawal by Subject | 4 | 10 | 24 |
Baseline characteristics
| Characteristic | Attention Control | Total | Intervention Group 2 (Video) | Intervention Group 1 (Face to Face) |
|---|---|---|---|---|
| Age, Continuous | 59.7 years STANDARD_DEVIATION 13.6 | 60.3 years STANDARD_DEVIATION 12.4 | 61.3 years STANDARD_DEVIATION 12 | 59.9 years STANDARD_DEVIATION 11.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 4 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 9 Participants | 22 Participants | 5 Participants | 8 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 16 Participants | 5 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 4 Participants | 10 Participants | 5 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 155 Participants | 460 Participants | 152 Participants | 153 Participants |
| Region of Enrollment United States | 172 Participants | 514 Participants | 171 Participants | 171 Participants |
| Sex: Female, Male Female | 132 Participants | 386 Participants | 129 Participants | 125 Participants |
| Sex: Female, Male Male | 40 Participants | 128 Participants | 42 Participants | 46 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 172 | 0 / 171 | 0 / 171 |
| other Total, other adverse events | 0 / 172 | 0 / 171 | 0 / 171 |
| serious Total, serious adverse events | 0 / 172 | 0 / 171 | 0 / 272 |
Outcome results
Primary
Caregiver Anxiety: Change From Baseline to Post-Intervention Exit
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Attention Control | Caregiver Anxiety: Change From Baseline to Post-Intervention Exit | -0.9 units on a scale | Standard Error 0.3 |
| Intervention Group 1 (Face to Face) | Caregiver Anxiety: Change From Baseline to Post-Intervention Exit | -2.0 units on a scale | Standard Error 0.4 |
| Intervention Group 2 (Video) | Caregiver Anxiety: Change From Baseline to Post-Intervention Exit | -0.7 units on a scale | Standard Error 0.4 |
p-value: 0.002Regression, Linear
p-value: 0.9Regression, Linear
p-value: 0.002Regression, Linear
Primary
Caregiver Quality of Life - Emotional: Change From Baseline to Post-Intervention Exit
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Attention Control | Caregiver Quality of Life - Emotional: Change From Baseline to Post-Intervention Exit | -0.1 units on a scale | Standard Error 0.2 |
| Intervention Group 1 (Face to Face) | Caregiver Quality of Life - Emotional: Change From Baseline to Post-Intervention Exit | 0.4 units on a scale | Standard Error 0.1 |
| Intervention Group 2 (Video) | Caregiver Quality of Life - Emotional: Change From Baseline to Post-Intervention Exit | 0.0 units on a scale | Standard Error 0.2 |
p-value: 0.003Regression, Linear
p-value: 0.16Regression, Linear
p-value: 0.17Regression, Linear
Primary
Caregiver Quality of Life - Financial: Change From Baseline to Post-Intervention Exit
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Attention Control | Caregiver Quality of Life - Financial: Change From Baseline to Post-Intervention Exit | 0.0 units on a scale | Standard Error 0.1 |
| Intervention Group 1 (Face to Face) | Caregiver Quality of Life - Financial: Change From Baseline to Post-Intervention Exit | 0.5 units on a scale | Standard Error 0.1 |
| Intervention Group 2 (Video) | Caregiver Quality of Life - Financial: Change From Baseline to Post-Intervention Exit | 0.0 units on a scale | Standard Error 0.2 |
p-value: 0.001Regression, Linear
p-value: 0.78Regression, Linear
p-value: 0.004Regression, Linear
Primary
Caregiver Quality of Life - Physical: Change From Baseline to Post-Intervention Exit
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Attention Control | Caregiver Quality of Life - Physical: Change From Baseline to Post-Intervention Exit | -0.4 units on a scale | Standard Error 0.1 |
| Intervention Group 1 (Face to Face) | Caregiver Quality of Life - Physical: Change From Baseline to Post-Intervention Exit | 0.2 units on a scale | Standard Error 0.1 |
| Intervention Group 2 (Video) | Caregiver Quality of Life - Physical: Change From Baseline to Post-Intervention Exit | -0.2 units on a scale | Standard Error 0.1 |
p-value: 0.001Regression, Linear
p-value: 0.48Regression, Linear
p-value: 0.01Regression, Linear
Primary
Caregiver Quality of Life - Social: Change From Baseline to Post-Intervention Exit
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Attention Control | Caregiver Quality of Life - Social: Change From Baseline to Post-Intervention Exit | -0.2 units on a scale | Standard Error 0.2 |
| Intervention Group 1 (Face to Face) | Caregiver Quality of Life - Social: Change From Baseline to Post-Intervention Exit | 0.2 units on a scale | Standard Error 0.1 |
| Intervention Group 2 (Video) | Caregiver Quality of Life - Social: Change From Baseline to Post-Intervention Exit | -0.4 units on a scale | Standard Error 0.2 |
p-value: 0.001Regression, Linear
p-value: 0.83Regression, Linear
p-value: 0.001Regression, Linear