Dataset Information

Telephone Assessment and Skill-Building Kit for Stroke Caregivers: A Randomized Controlled Clinical Trial.

ABSTRACT:

Background and purpose

There are few evidence-based programs for stroke family caregivers postdischarge. The purpose of this study was to evaluate efficacy of the Telephone Assessment and Skill-Building Kit (TASK II), a nurse-led intervention enabling caregivers to build skills based on assessment of their own needs.

Methods

A total of 254 stroke caregivers (primarily female TASK II/information, support, and referral 78.0%/78.6%; white 70.7%/72.1%; about half spouses 48.4%/46.6%) were randomized to the TASK II intervention (n=123) or to an information, support, and referral group (n=131). Both groups received 8 weekly telephone sessions, with a booster at 12 weeks. General linear models with repeated measures tested efficacy, controlling for patient hospital days and call minutes. Prespecified 8-week primary outcomes were depressive symptoms (with Patient Health Questionnaire Depressive Symptom Scale PHQ-9 ≥5), life changes, and unhealthy days.

Results

Among caregivers with baseline PHQ-9 ≥5, those randomized to the TASK II intervention had a greater reduction in depressive symptoms from baseline to 8, 24, and 52 weeks and greater improvement in life changes from baseline to 12 weeks compared with the information, support, and referral group (P<0.05); but not found for the total sample. Although not sustained at 12, 24, or 52 weeks, caregivers randomized to the TASK II intervention had a relatively greater reduction in unhealthy days from baseline to 8 weeks (P<0.05).

Conclusions

The TASK II intervention reduced depressive symptoms and improved life changes for caregivers with mild to severe depressive symptoms. The TASK II intervention reduced unhealthy days for the total sample, although not sustained over the long term.

Clinical trial registration

URL: https://www.clinicaltrials.gov. Unique identifier: NCT01275495.

SUBMITTER: Bakas T

PROVIDER: S-EPMC4659731 | biostudies-literature | 2015 Dec

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Telephone Assessment and Skill-Building Kit for Stroke Caregivers: A Randomized Controlled Clinical Trial.

Bakas Tamilyn T Austin Joan K JK Habermann Barbara B Jessup Nenette M NM McLennon Susan M SM Mitchell Pamela H PH Morrison Gwendolyn G Yang Ziyi Z Stump Timothy E TE Weaver Michael T MT

Stroke 20151108 12

<h4>Background and purpose</h4>There are few evidence-based programs for stroke family caregivers postdischarge. The purpose of this study was to evaluate efficacy of the Telephone Assessment and Skill-Building Kit (TASK II), a nurse-led intervention enabling caregivers to build skills based on assessment of their own needs.<h4>Methods</h4>A total of 254 stroke caregivers (primarily female TASK II/information, support, and referral 78.0%/78.6%; white 70.7%/72.1%; about half spouses 48.4%/46.6%) ...[more]

PMID: 26549488

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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:BackgroundCaring for people with dementia at home requires considerable time, organization and commitment. Therefore, informal caregivers of people with dementia are often overburdened. This study examined the effects of the telephone-based Talking Time intervention, which is an approach used to strengthen the psychological health-related quality of life (HRQoL) and social support of informal caregivers of people with dementia living at home.MethodsThis study was a Medical Research Council framework phase two randomized controlled trial. The intervention consisted of a preliminary talk, information booklet, six structured telephone-based support group meetings and a structured written self-evaluation of each support group meeting. The control participants performed their usual individual self-organized care. After completing the data collection, the control group received the Talking Time intervention for fidelity reasons. The primary outcome was the self-rated psychological HRQoL of the informal caregivers, which was measured with the mental component summary of the General Health Survey Questionnaire Short Form 12 (SF-12).ResultsThirty-eight informal caregivers and their relatives were included and allocated to the intervention or control groups (n = 19 each). After 3 months, the Talking Time intervention group demonstrated an increase in the self-rated psychological HRQoL scores, whereas the scores decreased in the control group. However, the standardized effect size of 1.65 (95% Confidence Interval, - 0.44 - 3.75) was not significant. Additionally, the secondary outcomes demonstrated no significant results. The differences between the groups in most outcomes were in the expected direction. No adverse effects were identified due to the intervention.ConclusionsThe Talking Time intervention is feasible and shows nonsignificant promising results with regard to the self-rated psychological HRQoL. After further adjustment, the intervention needs to be evaluated in a full trial.Trial registrationClinical Trials: NCT02806583 , June 9, 2016 (retrospectively registered).

Project description:Using robotic devices might improve recovery post-stroke, but the optimal way to apply robotic assistance has yet to be determined. The current study aimed to investigate whether training under the robotic active-assisted mode improves bimanual motor skill learning (biMSkL) more than training under the active mode in stroke patients. Twenty-six healthy individuals (HI) and 23 chronic hemiparetic stroke patients with a detectable lesion on MRI or CT scan, who demonstrated motor deficits in the upper limb, were randomly allocated to two parallel groups. The protocol included a two-day training on a new bimanual cooperative task, LIFT-THE-TRAY, under either the active or active-assisted modes (where assistance decreased in a pre-determined stepwise fashion) with the bimanual version of the REAplan® robotic device. The hypothesis was that the active-assisted mode would result in greater biMSkL than the active mode. The biMSkL was quantified by a speed-accuracy trade-off (SAT) before (T1) and immediately after (T2) training on days 1 and 2 (T3 and T4). The change in SAT after 2 days of training (T4/T1) indicated that both HI and stroke patients learned and retained the bimanual cooperative task. After 2 days of training, the active-assisted mode did not improve biMSkL more than the active mode (T4/T1) in HI nor stroke patients. Whereas HI generalized the learned bimanual skill to different execution speeds in both the active and active-assisted subgroups, the stroke patients generalized the learned skill only in the active subgroup. Taken together, the active-assisted mode, applied in a pre-determined stepwise decreasing fashion, did not improve biMSkL more than the active mode in HI and stroke subjects. Stroke subjects might benefit more from robotic assistance when applied "as-needed." This study was approved by the local ethical committee (Comité d'éthique médicale, CHU UCL Namur, Mont-Godinne, Yvoir, Belgium; Internal number: 54/2010, EudraCT number: NUB B039201317382) on July 14, 2016 and was registered with ClinicalTrials.gov (Identifier: NCT03974750) on June 5, 2019.

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:ImportanceInformal caregivers who provide home-based care frequently experience stress and burden that adversely affect their health-related quality of life (HRQOL).ObjectiveTo evaluate the efficacy of the Further Enabling Care at Home (FECH+) program for the HRQOL of caregivers of older adults discharged home from the hospital.Design, setting, and participantsThis multicenter, parallel, 2-group randomized clinical trial, with blinded baseline and outcome measurements, was conducted at 3 hospitals in 2 states in Australia. Recruitment took place between August 2020 and July 2022, and follow-up was performed for 12 months after hospital discharge. Participants were dyads of caregivers and patients. Eligible caregivers were aged 18 years or older who provided informal home-based care at least weekly for a patient aged 70 years or older. Caregivers were enrolled when their patient was discharged from the hospital. Dyads were randomly assigned to either the intervention or control group. Data analysis followed an intention-to-treat approach.InterventionCaregivers in the intervention group received the FECH+ program, structured nurse support of 6 telephone calls over 6 months after the patient's discharge plus usual discharge care. Caregivers in the control group received usual care alone.Main outcomes and measuresPrimary outcome was caregivers' HRQOL 6 months after discharge, which was measured using the Assessment of Quality of Life 8-Dimension (AQOL-8D). Secondary outcomes were caregivers' HRQOL 12 months after discharge as well as preparedness to care (measured using the Preparedness for Caregiving Scale), self-efficacy (measured using the Caregiver Inventory), and levels of strain and distress (measured using the Family Appraisal of Caregiving Questionnaire) at 6 and 12 months after discharge. Baseline and outcome measurements were administered by telephone at 3, 6, and 12 months after discharge.ResultsA total of 547 dyads (caregivers: 405 females [74.0%], mean [SD] age, 64.50 [12.82] years; patients: 296 females [54.1%], mean [SD] age, 83.16 [7.04] years for the intervention group and 83.45 [7.20] years for the control group) were included in the intention-to-treat analysis. There was no significant difference in caregivers' HRQOL between the 2 groups at the primary time point of 6 months (difference in AQOL-8D score, 0.01; 95% CI, -0.02 to 0.03; P = .62) after hospital discharge.Conclusions and relevanceIn this randomized clinical trial, the FECH+ program-a nurse telephone support intervention for caregivers of older adults after hospital discharge-did not significantly improve caregivers' HRQOL at 6 months after discharge compared with usual care. Additional examination is warranted into improving caregivers' HRQOL at the time of their patient's hospital discharge.Trial registrationAustralian New Zealand Clinical Trials Registry Identifier: ACTRN12620000060943.

Project description:BackgroundInformed consent is an essential element of clinical research. Obtaining consent, however, may be challenging. The use of the telephone for giving information and obtaining consent may be practical but little formal research has been done.MethodsWe examined the use of the telephone for the purpose of informing expectant mothers about The Danish Calmette Study; a randomized clinical trial assessing neonatal Bacille Calmette-Guérin vaccination. Expectant mothers received an invitation letter with a Participant Information Sheet about The Danish Calmette Study, the present trial, and a Consent Form. Two to 4 weeks later we contacted the mothers to discuss potential participation in the present trial. At this initial telephone contact, and after consent from the mothers, we randomized expectant mothers to receive the verbal information about The Danish Calmette Study by telephone, or at a face-to-face consultation. The primary outcome was a communication score, consisting of comprehension of information about The Danish Calmette Study and satisfaction with the information process. The outcome was measured using a questionnaire 2 days after the information was provided, and 2.5 months after the birth of the child.ResultsThe communication score obtained 2 days after information was given was significantly reduced in the telephone group, effect size -0.74 (95% confidence interval (CI), -1.11 to -0.36). The effect sizes of the subscores were -0.87 (95% CI, -1.25 to -0.49) for satisfaction and -0.22 (95% CI, -0.58 to 0.14) for comprehension. The effect sizes were slightly reduced when assessed 2.5 months after the birth.ConclusionThe communication score was reduced in the telephone group. This was due to a reduction in satisfaction, while no difference in the comprehension could be found in comparison to the control group. This may be ethically acceptable as both groups had high satisfaction scores.Trial registrationClinicalTrials.gov, registered on 5 October 2015 with trial registration number NCT02570061 .

Project description:BackgroundStrategies are needed to improve adherence to the blood pressure (BP) and low-density lipoprotein cholesterol (LDL-C) level recommendations after stroke and transient ischemic attack (TIA). We investigated whether nurse-led, telephone-based follow-up that included medication titration was more efficient than usual care in improving BP and LDL-C levels 36 months after discharge following stroke or TIA.MethodsAll patients admitted for stroke or TIA at Östersund hospital that could participate in the telephone-based follow-up were considered eligible. Participants were randomized to either nurse-led, telephone-based follow-up (intervention) or usual care (control). BP and LDL-C were measured one month after discharge and yearly thereafter. Intervention group patients who did not meet the target values received additional follow-up, including lifestyle counselling and medication titration, to reach their treatment goals (BP < 140/90 mmHg, LDL-C < 2.5 mmol/L). The primary outcome was the systolic BP level 36 months after discharge.ResultsOut of 871 randomized patients, 660 completed the 36-month follow-up. The mean systolic and diastolic BP values in the intervention group were 128.1 mmHg (95% CI 125.8-130.5) and 75.3 mmHg (95% CI 73.8-76.9), respectively. This was 6.1 mmHg (95% CI 3.6-8.6, p < 0.001) and 3.4 mmHg (95% CI 1.8-5.1, p < 0.001) lower than in the control group. The mean LDL-C level was 2.2 mmol/L in the intervention group, which was 0.3 mmol/L (95% CI 0.2-0.5, p < 0.001) lower than in controls. A larger proportion of the intervention group reached the treatment goal for BP (systolic: 79.4% vs. 55.3%, p < 0.001; diastolic: 90.3% vs. 77.9%, p < 0.001) as well as for LDL-C (69.3% vs. 48.9%, p < 0.001).ConclusionsCompared with usual care, a nurse-led telephone-based intervention that included medication titration after stroke or TIA improved BP and LDL-C levels and increased the proportion of patients that reached the treatment target 36 months after discharge.Trial registrationISRCTN Registry ISRCTN23868518 (retrospectively registered, June 19, 2012).

Dataset Information

Telephone Assessment and Skill-Building Kit for Stroke Caregivers: A Randomized Controlled Clinical Trial.

Background and purpose

Methods

Results

Conclusions

Clinical trial registration

Publications

Telephone Assessment and Skill-Building Kit for Stroke Caregivers: A Randomized Controlled Clinical Trial.

Similar Datasets

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