Dataset Information

Comparing treatment fidelity between study arms of a randomized controlled clinical trial for stroke family caregivers.

ABSTRACT:

Objective

To compare treatment fidelity among treatment arms in the Telephone Assessment and Skill-Building Kit study for stroke caregivers (TASK II) with respect to: 1) protocol adherence; 2) intervention dosage and 3) nurse intervener perspectives.

Design

A randomized controlled clinical trial design.

Setting

Urban, community, midwestern United States.

Subjects

A total of 254 stroke caregivers (mean ±SD age, 54.4 ±11.8 years), 55 (22.0%) males and 199 (78.4%) females) randomized to the TASK II intervention (n=123) or an Information, Support, and Referral comparison group (n=131).

Interventions

TASK II participants received the TASK II Resource Guide; Information, Support, and Referral participants received a standard caregiver brochure. At approximately 8 weeks after discharge, both groups received 8 weekly calls from a nurse, with a booster call 4 weeks later.

Measures

Protocol adherence was evaluated with the TASK II Checklist for Monitoring Adherence. Intervention dosage was measured by the number of minutes caregivers spent reading materials and talking with the nurse. Nurse intervener perspectives were obtained through focus groups.

Results

Protocol adherence was 80% for the TASK II and 92% for the Information, Support, and Referral. As expected, intervention dosage differed between TASK II and Information, Support, and Referral with respect to caregiver time spent reading materials (t=-6.49; P<.001) and talking with the nurse (t=-7.38; P<.001). Focus groups with nurses yielded further evidence for treatment fidelity and recommendations for future trials.

Conclusions

These findings substantiate treatment fidelity in both study arms of the TASK II stroke caregiver intervention trial (NIH R01NR010388; ClinicalTrials.govNCT01275495).

SUBMITTER: McLennon SM

PROVIDER: S-EPMC4746107 | biostudies-literature | 2016 May

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Comparing treatment fidelity between study arms of a randomized controlled clinical trial for stroke family caregivers.

McLennon Susan M SM Hancock Rebecca D RD Redelman Kathleen K Scarton Lisa J LJ Riley Elizabeth E Sweeney Bobbie B Habermann Barbara B Jessup Nenette M NM Bakas Tamilyn T

Clinical rehabilitation 20150507 5

<h4>Objective</h4>To compare treatment fidelity among treatment arms in the Telephone Assessment and Skill-Building Kit study for stroke caregivers (TASK II) with respect to: 1) protocol adherence; 2) intervention dosage and 3) nurse intervener perspectives.<h4>Design</h4>A randomized controlled clinical trial design.<h4>Setting</h4>Urban, community, midwestern United States.<h4>Subjects</h4>A total of 254 stroke caregivers (mean ±SD age, 54.4 ±11.8 years), 55 (22.0%) males and 199 (78.4%) femal ...[more]

PMID: 25952589

Similar Datasets

Project description:BackgroundThe majority of stroke survivors return to their homes and need assistance from family caregivers to perform activities of daily living. These increased demands coupled with the lack of preparedness for their new roles lead to a high risk for caregivers developing depressive symptoms and other negative outcomes. Follow-up home support and problem-solving interventions with caregivers are crucial for maintaining stroke survivors in their homes. Problem-solving interventions are effective but are underused in practice because they require large amounts of staff time to implement and are difficult for caregivers logistically.ObjectiveThe aim of this study is to test a problem-solving intervention for stroke caregivers that can be delivered over the telephone during the patient's transitional care period (time when the stroke survivor is discharged to home) followed by 8 asynchronous online sessions.MethodsThe design is a two-arm parallel randomized clinical trial with repeated measures. We will enroll 240 caregivers from eight Veterans Affairs (VA) medical centers. Participants randomized into the intervention arm receive a modified problem-solving intervention that uses telephone and web-based support and training with interactive modules, fact sheets, and tools on the previously developed and nationally available Resources and Education for Stroke Caregivers' Understanding and Empowerment Caregiver website. In the usual care group, no changes are made in the information, discharge planning, or care the patients who have had a stroke normally receive, and caregivers have access to existing VA resources (eg, caregiver support line, self-help materials). The primary outcome is a change in caregiver depressive symptoms at 11 and 19 weeks after baseline data collection. Secondary outcomes include changes in stroke caregivers' burden, knowledge, positive aspects of caregiving, self-efficacy, perceived stress, health-related quality of life, and satisfaction with care and changes in stroke survivors' functional abilities and health care use. The team will also determine the budgetary impact, facilitators, barriers, and best practices for implementing the intervention. Throughout all phases of the study, we will collaborate with members of an advisory panel.ResultsStudy enrollment began in June 2015 and is ongoing. The first results are expected to be submitted for publication in 2021.ConclusionsThis is the first known study to test a transitional care and messaging center intervention combined with technology to decrease caregiver depressive symptoms and to improve the recovery of stroke survivors. If successful, findings will support an evidence-based model that can be transported into clinical practice to improve the quality of caregiving post stroke.Trial registrationClinicalTrials.gov NCT01600131; https://www.clinicaltrials.gov/ct2/show/NCT01600131.International registered report identifier (irrid)DERR1-10.2196/21799.

Project description:Background and objectivesThe number of persons living with dementia (PLWD) in the United States will reach 16 million by 2050. Behavioral and psychological symptoms of dementia challenge family caregivers and contribute to negative caregiver outcomes such as burden and depression. Available technology can support the delivery of effective interventions to families providing dementia care at home. The Supporting Family Caregivers with Technology for Dementia Home Care (FamTechCare) randomized controlled trial evaluated the effects of a telehealth intervention on caregiver outcomes.Research design and methodsThe FamTechCare intervention provides tailored dementia-care strategies to in-home caregivers based on video recordings caregivers submit of challenging care situations. An expert team reviews the videos and provides individualized interventions weekly for the experimental group. In the telephone-support attention control group, caregivers receive feedback from an interventionist via the telephone based on caregiver retrospective recall of care challenges. Effects of the intervention on caregiver outcomes, including burden, depression, sleep disturbance, competence, desire to institutionalize the PLWD, and caregiver reaction to behavioral symptoms were evaluated by fitting linear mixed regression models to changes in the outcomes measured at 1 and 3 months.ResultsFamTechCare caregivers (n = 42) had greater reductions in depression (p = .012) and gains in competence (p = .033) after 3 months compared to the attention control group (n = 41). Living in rural areas was associated with a reduction in depression for FamTechCare caregivers (p = .002). Higher level of education was associated with greater improvements or lesser declines in burden, competence, and reaction to behavioral symptoms for both the FamTechCare and attention control caregivers.Discussion and implicationsThis research demonstrated benefits of using available technology to link families to dementia care experts using video-recording technology. It provides a foundation for future research testing telehealth interventions, tailored based on rich contextual data to support families, including those in rural or remote locations.

Project description:BackgroundHome-based rehabilitation has been shown to be useful for stroke survivors to participate in daily life activities and return to their families. However, many home-based stroke survivors face challenges in the lack of professional guidance, rational training plans, and insufficient motivation, which will affect their rehabilitation outcomes to varying degrees. Though occupational therapy and coaching are widely recommended for stroke rehabilitation, studies that combine these two interventions via telerehabilitation in home-based rehabilitation are limited. Hence, this study will explore whether coaching-based teleoccupational guidance (CTG) will help stroke survivors and caregivers obtain satisfactory outcomes.MethodsThis single-blind (assessor), two-arm parallel superior randomised controlled trial will be conducted in the Hebei General Hospital, Shijiazhuang, China. Ninety-two participant dyads in home-based rehabilitation will be recruited and randomised to either CTG (intervention group) or a standard telerehabilitation group (control group). Participant dyads in the intervention group will follow a 6-step circle procedure and receive 12 teleoccupational coaching sessions over 3 months via WeChat. Data will be collected at baseline, after the intervention (3 months), and follow-up (6 months). The Reintegration to Normal Living Index will be the primary outcome to assess the participation of stroke survivors. Secondary outcomes will not only involve an observation of changes in activities of daily living, intrinsic motivation, motor function, and quality of life of stroke survivors but also will focus on the caregivers' perceived benefit and care burden. Discussion. This trial will assess the effects of CTG compared with standard telerehabilitation. We believe that the results of this study will add to the understanding of occupational therapy for stroke survivors in home-based rehabilitation and provide a reference for developing health policy and facilitating other chronic management. Trial Registration Number. The Chinese Clinical Trial Registry ChiCTR2200061107.

Project description:BackgroundAs dementia progresses, patients exhibit various psychological and behavioral symptoms, imposing a significant burden on families and society, including behavioral and psychological symptoms of dementia. However, caregivers lack professional care knowledge and skills, making it difficult for them to effectively cope with the diverse challenges of caregiving. Therefore, it is necessary to provide caregivers with professional knowledge and skills guidance.ObjectiveThis study aimed to analyze the impact of internet-based training on behavioral and psychological symptoms of dementia in patients, and explore how this training model affects the caregiving abilities and caregiving burden of the family caregivers of patients with dementia.MethodsUsing a consecutive enrollment method, the Department of Geriatrics at Zhejiang Hospital (Zhejiang, China) recruited 72 informal caregivers of patients with dementia. These caregivers were randomly divided into an intervention group and a control group, with 36 participants in each group. The intervention group underwent caregiver skill training via a web-based platform, whereas the control group initially received face-to-face follow-up guidance and was subsequently offered web-based training after 6 months. To assess the effectiveness of the intervention program, we used the Neuropsychiatric Inventory Questionnaire (NPI-Q), the Chinese version of the Zarit Burden Interview (CZBI), and the Sense of Competence in Dementia Care Staff Scale (SCIDS) for evaluations conducted before the intervention, 3 months after the intervention, and 6 months after the intervention.ResultsBetween July 2019 and December 2020, a total of 66 patients successfully completed the intervention and follow-up. After 6 months of intervention, the NPI-Q score of the intervention group was 3.18 (SD 3.81), the CZBI score was 10.97 (SD 5.43), and the SCIDS score was 71.88 (SD 4.78). The NPI-Q score of the control group was 8.09 (SD 8.52), the CZBI score was 30.30 (SD 13.05), and the SCIDS score was 50.12 (SD 9.10). There were statistically significant differences in NPI-Q (P=.004), CZBI (P<.001), and SCIDS scores (P<.001) between the intervention group and the control group. Repeated measures analysis of variance showed that compared with before the intervention, there were statistically significant differences in CZBI (P<.001) and SCIDS (P<.001) scores 3 months after the intervention, while the difference in NPI-Q (P=.11) scores was not significant. The total scores of NPI-Q (P<.001), CZBI (P<.001), and SCIDS (P<.001) were significantly improved 6 months after the intervention. In addition, the results of the covariance analysis showed that after excluding the time effect, the web-based training intervention significantly reduced the NPI-Q score (-2.79, 95% CI -4.38 to -1.19; P<.001) of patients with dementia and the CZBI score (-13.52, 95% CI -15.87 to -11.16; P<.001) of caregivers, while increasing the SCIDS score (12.24, 95% CI 9.02-15.47; P<.001).ConclusionsInternet-based training could significantly reduce the level of behavioral symptoms in older patients with dementia and alleviate the burden on caregivers, enhancing their caregiving abilities. Our results confirmed the effectiveness and feasibility of web-based training, which was of great significance in providing caregiving knowledge training for informal caregivers of persons with dementia.

Project description:BackgroundDepressive symptoms are a significant psychological complication of stroke, impacting both survivors and informal caregivers of survivors. Randomized controlled trials are needed to determine optimal non-pharmacological strategies to prevent or ameliorate depressive symptoms in stroke survivors and their informal caregivers.MethodsA prospective, randomized, parallel-group, single-center, feasibility study. Participants were assigned to a 4-week meditation intervention or expressive writing control group. The intervention comprised four facilitator-led group meditation sessions, one session per week and building upon prior session(s). Descriptive statistics were used to examine the proportion of eligible individuals who enrolled, retention and adherence rates, and the proportion of questionnaires completed. Data were collected at baseline, immediately after the 4-week intervention period, and 4 and 8 weeks after the intervention period. Secondary analysis tested for changes in symptoms of depression (Center for Epidemiologic Studies-Depression [CES-D]), anxiety [State-Trait Anxiety Inventory for Adults (STAI)], and pain (Brief Pain Inventory-Short Form) in the intervention group via paired t tests. Linear mixed models were used to compare longitudinal changes in the measures between the groups. Intervention and trial design acceptability were preliminary explored.ResultsSeventy-one (77%) individuals enrolled and 26 (37%) completed the study (baseline and 8-week post-intervention visits completed). Forty-two (66%) participants completed baseline and immediate post-intervention visits. Mean questionnaire completion rate was 95%. The median meditation group session attendance rate for the intervention group was 75.0%, and the mean attendance rate was 55%. Non-significant reductions in CES-D scores were found. Paired t tests for stroke survivors indicated a significant reduction from baseline through week 8 in BPI-sf severity scores (p = 0.0270). Repeated measures analysis with linear mixed models for informal caregivers indicated a significant reduction in in STAI-Trait scores (F [3,16.2] = 3.28, p = 0.0479) and paired t test showed a significant reduction from baseline to week 4 in STAI-Trait scores (mean = - 9.1250, 95% CI [- 16.8060 to 1.4440], p = 0.0262). No between-group differences were found.ConclusionsFuture trials will require strategies to optimize retention and adherence before definitive efficacy testing of the meditation intervention.Trial registrationClinicalTrials.gov Identifier: NCT03239132. Registration date: 03/08/2017.

Project description:BackgroundStroke has profound impacts on families. Often, family members, including stroke survivors and the person who takes up the role of the primary caregiver, would encounter demands on finances, rehabilitation arrangement, and even conflicts. Hence, a family-oriented intervention is expected to enable families to rebuild internal and external resources to achieve optimal rehabilitation and community reintegration.ObjectiveThis study aims to describe a design of a two-tier family-oriented care management intervention for enhancing the family functioning and care capacity of the caregivers of stroke survivors.MethodsThe two-tier care management intervention was guided by a standardized protocol conducted by trained professional care managers (first tier) with the support of trained volunteers (second tier), which lasted for 8-12 weeks. Participants were recruited through collaborating hospitals according to inclusion and exclusion criteria. In order to examine the effectiveness and cost-effectiveness of the two-tier care management intervention, a two-arm randomization multicenter study was designed, including an active comparison group, which was guided by a standardized protocol conducted by trained volunteers. Dyadic participants, including both stroke survivors and their primary caregivers for both groups, were invited to participate in a questionnaire survey using standardized and purposefully developed measures 3 times: before the intervention, immediately after the intervention, and 2 months after the intervention. The primary outcome was family functioning measured by the Family Role Performance Scale and Family Assessment Device-General Functioning Scale. The secondary outcomes included caregiving burden, depressive symptoms, care management strategies, and the incremental cost-effectiveness ratio.ResultsRecruitment began in January 2017 and was completed at the end of April 2019. Data collection was completed at the end of March 2020. As of March 2020, enrollment has been completed (n=264 stroke caregivers). A total of 200 participants completed the baseline questionnaires. We aim to publish the results by mid-2021.ConclusionsThis study successfully developed a two-tier care management protocol that aims to enhance the family functioning of the caregivers of stroke survivors. Guided by a standardized protocol, this family-oriented two-tier intervention protocol was found to be feasible among Chinese families.Trial registrationClinicalTrials.gov NCT03034330; https://ichgcp.net/clinical-trials-registry/NCT03034330.International registered report identifier (irrid)RR1-10.2196/16703.

Dataset Information

Comparing treatment fidelity between study arms of a randomized controlled clinical trial for stroke family caregivers.

Objective

Design

Setting

Subjects

Interventions

Measures

Results

Conclusions

Publications

Comparing treatment fidelity between study arms of a randomized controlled clinical trial for stroke family caregivers.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets