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Completed

NCT Number: NCT02080910

A Psychoeducational Intervention for Stroke Family Caregivers

This is a randomized controlled trial with a 3-month psychoeducational program as intervention, followed by a 3 month observational period. The purpose of this study was to examine whether a psychoeducational program focusing on equipping caregivers with problem-solving skills would improve caregiver's problem-solving abilities, their psychological responses and caregiving resources, and would minimize the use of health and social services among stroke survivors.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Prince of Wales Hospital, Shatin Hospital, Tai Po Hospital

Hong Kong SAR, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

(caregiver):

  • Family member of stroke survivor
  • Chinese adult
  • Live with stroke survivors
  • Primary caregiver
  • Being able to communicate with the researcher

Inclusion criteria

(stroke survivor):

  • Chinese adult with diagnosis of stroke
  • Live at home after discharge
  • Being able to understand and to give consent

Exclusion criteria

(caregiver and stroke survivor):

  • History of self-reported doctor-diagnosed psychiatric illness
  • (stroke survivor): being mild to totally independent

Treatment and study plan

Psychoeducation

Behavioral

Primary outcomes

  1. Caregivers' change in depressive symptom severity from baseline

    Time frame: 3 month post intervention

    Change in depressive symptoms severity, as measured by the 10-item Center for Epidemiological Studies Depression (Chinese version), will be analyzed by the GEE model

  2. Caregiver's change in perceived mental health from baseline

    Time frame: 3 months post intervention

    Change in perceived mental health, as measured by the Chinese (Hong Kong) Medical Outcomes Study 12-item Short Form Health Survey version 2 (SF-12v2), its mental component summary score will be analyzed by the GEE model

  3. Caregiver's change in caregiving burden

    Time frame: at immediate post-intervention, 1-month post-intervention, 3-month post-intervention

    End-point between-group differences of the caregiving burden, as measured by the Caregiving Strain Index (Chinese version), will be analyzed by multiple regression analysis

  4. Caregiver's change in caregiving competence from baseline

    Time frame: 3 months post intervention

    Change in caregiving competence, as measured by the Caregiving Competence Scale (Chinese version), will be analyzed by the GEE model

Secondary outcomes

  1. Caregiver's change in self-appraised problem-solving abilities from baseline

    Time frame: 3 months post intervention

    Change in self-appraised problem-solving abilities, as measured by the Problem Solving Inventory (Chinese version), will be analyzed using the Generalized Estimating Equations (GEE) model

  2. Caregiver's change in family functioning from baseline

    Time frame: 3 months post intervention

    Change in family functioning, as measured by the McMaster Model of Family Assessment Device (Chinese version), will be analyzed using the GEE model

  3. Caregiver's change in perceived social support from baseline

    Time frame: 3 months post intervention

    Change in perceived social support, as measured by the Six-item Social Support Questionnaire (Chinese version), will be analyzed using the GEE model

  4. Caregiver's change in perceived physical health from baseline

    Time frame: 3 months post intervention

    Change in perceived physical health, as measured by the Chinese (Hong Kong) SF-12v2 (Physical Component Summary Score), will be analyzed by the GEE model

  5. Caregiving-related injuries

    Time frame: at immediate post-intervention, 1-month post-intervention, 3-month post-intervention

    End-point between-group differences of the self-reported caregiving related injuries will be analyzed using Chi square statistics

  6. Stroke-related hospital readmission (stroke survivors)

    Time frame: at immediate post-intervention, 1-month post-intervention, 3-month post-intervention

    End-point between-group differences of the self-reported stroke-related hospital readmission, such as falls, recurrent stroke, will be analyzed using Chi square statistics

  7. Placement to residential/nursing care home (stroke survivors)

    Time frame: at immediate post-intervention, 1-month post-intervention, 3-month post-intervention

    End-point between-group differences of the placement to residential/nursing care home of stroke survivors will be analyzed by the Chi square statistics

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

The Effects of a Psychoeducational Intervention on Stroke Family Caregiver Outcomes and the Use of Health and Social Services Among Stroke Survivors: A Randomized Controlled Trial

Important dates

Primary completion
2014
Study completion
2014
First posted
Mar 7, 2014
Registry last updated
Jul 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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