Internet and Telephone Support Intervention for Stroke Caregivers

Depression Clinical Trial

Official title:

Internet and Telephone Support Intervention for Stroke Caregivers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04348851
• Other study ID #: D1395-P
• Status: Completed
• Phase: N/A
• Start date: October 1, 2014
• Est. completion date: October 1, 2016

Study information

• Verified date: May 2020
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will test a problem-solving and support intervention for caregivers of veterans with stroke. The investigators will assign caregivers to one for four groups: 4-session intervention, 8-session intervention, attention control (active listening), or standard care. The investigators will assess the impact of the intervention on caregiver outcomes (depression, burden, stress, problem-solving abilities, self-efficacy, and quality of life) and veteran outcomes (functional abilities).

Description:

Background: Caregiver depression and burden are common following a family member's stroke and are major contributors of stroke survivors' functional recovery, resource use, and institutionalization. Previous studies reveal that problem-solving interventions are effective in improving caregiver and Veteran outcomes post-stroke. However, most of these studies were burdensome for caregivers and labor intensive because they involved multiple, face-to-face sessions. To overcome this shortcoming, the long-term goal is to implement caregiver programs that involve low-cost, evidence-based interventions that can be sustained in routine clinical practice. The investigators' immediate objective is to pilot test a problem-solving intervention that uses telephone support plus the Internet (i.e., the team's previously developed and nationally available RESCUE website) to improve the quality caregiving and the rehabilitation of Veterans. This pilot randomized controlled trial (RCT) simulates all aspects of a planned, future merit review proposal. This work builds on the team's extensive experience in caregiver education.

Aim #1: To explore the impact of a 4-session and 8-session Internet and telephone support intervention on stroke caregiver and Veteran outcomes when compared to an attention-control condition and standard care. The investigators will obtain preliminary data on effect estimates, group differences, and information on variability, correlations, and data ranges. Data will inform a sample size calculation for the larger trial and provide preliminary information on the impact of different doses of the intervention.

Aim #2: Determine caregivers' perceptions of the interventions and the attention control condition: Acceptability, facilitators/barriers, credibility of the nurse interventionists. The investigators will learn the strengths and weaknesses of the project, thereby helping to make improvements in the investigators' future merit project.

Methods: The investigators will conduct a four-arm, randomized controlled trial with three assessment points (baseline and two post-tests) and use mixed methods to determine caregivers' perceptions of the intervention and the attention control condition. The investigators will enroll 48 stroke caregivers whose Veterans receive care in VISN8. Eligible caregivers will complete baseline measures and then will be randomized to four arms: 1) 4-session intervention, 2) 8-session intervention, 3) attention control condition, or 4) standard care. Registered nurses will conduct the combined Internet and telephone intervention and the attention-control condition. The intervention is based on the relational/problem-solving model of stress originally developed by D-Zurilla and Nezu. The investigators will modify the traditional, problem-solving intervention by adding web-based training using interactive modules, factsheets, and tools on the national RESCUE Stroke Caregiver website. (http://www.cidrr8.research.va.gov/rescue/). For the first post-test, a research team member will telephone caregivers to answer questions on instruments with established reliability and validity. A second post-test will be conducted approximately four to five months after the first post-test assessment to evaluate longer-term effects. Qualitative interviews will be conducted with 18 caregivers to obtain in-depth perceptions of the credibility of nurses, and value, facilitators, and barriers of the intervention and the attention control condition.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: October 1, 2016
• Est. primary completion date: September 19, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

All non-paid caregivers of Veterans with a primary diagnosis of stroke, discharged to home from a medical or rehabilitation facility are eligible for participation if they meet the following criteria:

• have caregiving responsibility for a Veteran who has a diagnosis of stroke (ICD9 codes for stroke: 430-438) within the last 2.5 years and who have at least one activity of daily living (ADL), cognitive, or speech deficit related to stroke

• score 1 or greater on the Perceived Stress Scale

• have Internet access and ability

• are reachable by their cell or home phones

• read English at a seventh-grade reading level or better

• agree to random assignment to a study arm

Exclusion Criteria:

The investigators will exclude caregivers who fail to meet one or more of the inclusion criteria and whose Veterans:

• have a life expectancy of less than 6 months

• are receiving hospice/palliative care or are residing in a community living center

• Life expectancy will be determined by reviewing the electronic health record (EHR) and conferring with our physician and clinical team members

Related Conditions & MeSH terms

• Depression
• Quality of Life
• Recovery of Function
• Self Efficacy
• Stress

Intervention

Behavioral:
• Caregiver problem-solving
Registered nurses will conduct the combined Internet and telephone intervention condition. The intervention is based on the relational/problem-solving model of stress originally developed by D-Zurilla and Nezu. The investigators will modify the traditional, problem-solving intervention by adding web-based training using interactive modules, factsheets, and tools on our national RESCUE Stroke Caregiver website. (http://www.cidrr8.research.va.gov/rescue
• Attention Control
The RNs will only provide active listening and paraphrasing. The RNs will ask caregivers to talk about their caregiver experiences. The nurses will not provide advice, but rather direct caregivers to access information on the Caregiver Family Alliance website (www.caregiver.org) for managing problems or to contact their healthcare

Locations

Country	Name	City	State
United States	North Florida/South Georgia Veterans Health System, Gainesville, FL	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (1)

LeLaurin J, Schmitzberger M, Eliazar-Macke N, Freytes IM, Dang S, Uphold C. A commentary on methodological issues in stroke caregiver research: lessons learned from three RESCUE intervention studies. Top Stroke Rehabil. 2019 Jul;26(5):399-404. doi: 10.108 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Depressive Symptoms	Changes in depressive symptoms will be measured with the Center for Epidemiologic Studies Depression (CES-D) scale. The CES-D is a 20-item, 4-point Likert scale ranging from never (0) to most of the time (3). Possible scores range from 0-60 with higher scores indicating more symptoms. It has been used in numerous studies with caregivers and has good reliability and validity.	9 weeks after baseline
Primary	Change in Caregiver Burden	Changes in burden will be measured by the Short Version of the Zarit Burden Interview (S-ZBI). This 12-item instrument was reduced from the original 29-item instrument. This instrument is scored on a 5-point Likert scale ranging from 0 (never) to 4 (nearly always). Possible scores range from 0-48 with higher scores indicating higher burden. The instrument was originally developed to measure dementia caregiver burden, but, the S-ZBI has been used in stroke caregiver studies and items are appropriate for other caregiver populations.	9 weeks after baseline
Primary	Change in Depressive Symptoms	Change in depressive symptoms will be measured with the Center for Epidemiologic Studies Depression (CES-D) scale. The CES-D is a 20-item, 4-point Likert scale ranging from never (0) to most of the time (3). Possible scores range from 0-60 with higher scores indicating more symptoms. It has been used in numerous studies with caregivers and has good reliability and validity.	25 weeks after baseline
Primary	Change in Caregiver Burden	Changes in burden will be measured by the Short Version of the Zarit Burden Interview. This 12-item instrument was reduced from the original 29-item instrument. This instrument is scored on a 5-point Likert scale ranging from 0 (never) to 4 (nearly always). Possible scores range from 0-48 with higher scores indicating higher burden. The instrument was originally developed to measure dementia caregiver burden, but, the S-ZBI has been used in stroke caregiver studies and items are appropriate for other caregiver populations.	25 weeks after baseline
Secondary	Change in Health-Related Quality of Life - Physical Scale	Changes in health-related quality of life will be measured by the Rand 12-item Health Survey (VR-12). The VR-12 items are scored on a 3-point or 5-point Likert scale ranging from. It consists of physical and emotional scales. Scores for each scale are calculated by using an algorithm and scores are standardized using a T-score metric with a mean of 50 and standard deviation of 10. Higher scores indicate better health-related quality of life.	9 weeks after baseline
Secondary	Change in Perceived Stress	Changes in perceived stress will be measured by the Perceived Stress Scale (PSS-4). The 4-item measure asses stress experienced in the last month on a 5-point Likert scale ranging from 0 (never) to 4 (very often). Scores range from 0-16, with higher scores indicating more stress.	9 weeks after baseline
Secondary	Change in Stroke Knowledge	Change in stroke knowledge will be measured by the Stroke Knowledge Instrument developed by the National Institutes of Health. This 7-item tool consists of true/false and multiple choice responses. Scores range from 0-7, with higher scores indicating more stroke knowledge.	9 weeks after baseline
Secondary	Changes in Problem-Solving Abilities	Changes in problem-solving abilities will be measured by the Social Problem-Solving Inventory - Short Form (SPSI-SF). The SPSI-SF is a 25-item tool consisting of five subscales (problem-solving orientation, rational problem-solving, negative problem-solving, impulsivity, avoidance style problem solving). Raw scores must first be converted to standard scores, which range from 0-20 for each of the 5 subscales. Higher scores on the problem-solving orientation and rational problem-solving scales indicate better problem-solving abilities, while higher scores on the negative problem-solving, impulsivity, and avoidance-style problem solving indicate worse problem-solving abilities. Total scores range from 0-100 with higher scores indicating better problem-solving abilities.	9 weeks after baseline
Secondary	Caregiving Self-efficacy	Changes in caregiving self-efficacy will be measured by the Caregiver Self-Efficacy Scale. This 14-item tool measures caregivers' judgments regarding their ability to perform effectively. Responses are binary (0=no, 1=yes) and scores range from 0-14, with higher scores indicating greater self-efficacy.	9 weeks after baseline
Secondary	Change in Veteran Functional Abilities	Change in Veteran functional abilities will be measured by the Barthel Index, which measures patients' abilities to perform 10 self-care tasks. Response options vary for each item and are scored on 5-point increments (e.g., 0=unable, 5=needs help, 10-independent). Total scores range from 0-100 with higher scores indicating greater functional abilities.	9 weeks after baseline
Secondary	Change in Health-Related Quality of Life - Physical Scale	Changes in health-related quality of life will be measured by the Rand 12-item Health Survey (VR-12). The VR12 items are scored on a 3-point or 5-point Likert scale ranging from. It consists of physical and emotional scales. Scores for each scale are calculated by using an algorithm and scores are standardized using a T-score metric with a mean of 50 and standard deviation of 10. Higher scores indicate better health-related quality of life.	25 weeks after baseline
Secondary	Change in Perceived Stress	Changes in stress will be measured by the Perceived Stress Scale (PSS-4). The 4-item measure asses stress experienced in the last month on a 5-point Likert scale ranging from 0 (never) to 4 (very often). Scores range from 0-16, with higher scores indicating more stress.	25 weeks after baseline
Secondary	Change in Stroke Knowledge	Change in stroke knowledge will be measured by the Stroke Knowledge Instrument developed by the National Institutes of Health. This 7-item tool consists of true/false and multiple choice responses. Scores range from 0-7, with higher scores indicating more stroke knowledge.	25 weeks after baseline
Secondary	Change in Problem-Solving Abilities	Changes in problem-solving abilities will be measured by the Social Problem-Solving Inventory - Short Form (SPSI-SF). The SPSI-SF is a 25-item tool consisting of five subscales (problem-solving orientation, rational problem-solving, negative problem-solving, impulsivity, avoidance style problem solving). Raw scores must first be converted to standard scores, which range from 0-20 for each of the 5 subscales. Higher scores on the problem-solving orientation and rational problem-solving scales indicate better problem-solving abilities, while higher scores on the negative problem-solving, impulsivity, and avoidance-style problem solving indicate worse problem-solving abilities. Total scores range from 0-100 with higher scores indicating better problem-solving abilities.	25 weeks after baseline
Secondary	Change in Caregiving Self-Efficacy	Changes in caregiving self-efficacy are measured by the Caregiver Self-Efficacy Scale. This 14-item tool measures caregivers' judgments regarding their ability to perform effectively. Responses are binary (0=no, 1=yes) and scores range from 0-14, with higher scores indicating greater self-efficacy.	25 weeks after baseline
Secondary	Change in Veteran Functional Abilities	Change in Veteran functional abilities will be measured by the Barthel Index, which measures patients' abilities to perform 10 self-care tasks. Response options vary for each item and are scored on 5-point increments (e.g., 0=unable, 5=needs help, 10-independent). Total scores range from 0-100 with higher scores indicating greater functional abilities.	25 weeks after baseline
Secondary	Change in Health-Related Quality of Life - Mental Scale	Changes in health-related quality of life will be measured by the Rand 12-item Health Survey (VR-12). The VR12 items are scored on a 3-point or 5-point Likert scale ranging from. It consists of physical and emotional scales. Scores for each scale are calculated by using an algorithm and scores are standardized using a T-score metric with a mean of 50 and standard deviation of 10. Higher scores indicate better health-related quality of life.	9 weeks after baseline
Secondary	Change in Health-Related Quality of Life - Mental Scale	Changes in health-related quality of life will be measured by the Rand 12-item Health Survey (VR-12). The VR12 items are scored on a 3-point or 5-point Likert scale ranging from. It consists of physical and emotional scales. Scores for each scale are calculated by using an algorithm and scores are standardized using a T-score metric with a mean of 50 and standard deviation of 10. Higher scores indicate better health-related quality of life.	25 weeks after baseline