Internet and Telephone Support Intervention for Stroke Caregivers

NCT04348851 | Completed Results

• 1 other identifier: D1395-P
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

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

Keywords

stroke; caregiving

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (14)

• Change in Health-Related Quality of Life - Physical Scale

  9 weeks after baseline

• Change in Perceived Stress

  9 weeks after baseline

• Change in Stroke Knowledge

  9 weeks after baseline

• Changes in Problem-Solving Abilities

  9 weeks after baseline

• Caregiving Self-efficacy

  9 weeks after baseline

Study Arms (4)

4-Week Intervention

EXPERIMENTAL

Registered nurses (RNs) 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/).

Behavioral: Caregiver problem-solving

8-Week Intervention

EXPERIMENTAL

Registered nurses (RNs) 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/).

Behavioral: Caregiver problem-solving

8-Week Attention Control

ACTIVE COMPARATOR

The Registered Nurses (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 provider.

Behavioral: Attention Control

Standard Care

NO INTERVENTION

Caregivers receiving standard of care

Interventions

Caregiver problem-solving BEHAVIORAL

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

4-Week Intervention; 8-Week Intervention

Attention Control BEHAVIORAL

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

8-Week Attention Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

North Florida/South Georgia Veterans Health System, Gainesville, FL

Gainesville, Florida, 32608, United States

Location

Related 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: 10.1080/10749357.2019.1607485. Epub 2019 Apr 30.

  PMID: 31038012 RESULT

MeSH Terms

Conditions

Depression; Stroke

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Dr. Constance Uphold
• Organization: North Florida/South Georgia Veterans Health System

connie.uphold@va.gov

352-548-6000

Study Officials

• Constance R. Uphold, PhD MS BS

  North Florida/South Georgia Veterans Health System, Gainesville, FL

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The primary investigator and staff collecting outcome data will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Four-arm randomized controlled trial

Study Record Dates

• First Submitted: April 13, 2020
• First Posted: April 16, 2020
• Study Start: October 1, 2014
• Primary Completion: September 19, 2016
• Study Completion: October 1, 2016
• Last Updated: June 2, 2020
• Results First Posted: May 18, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)