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Completed

NCT Number: NCT01355029

Evaluation of the Stroke Caregiver Education and Support Program

The study will be evaluating to a 4 week education and support program for stroke caregivers. The 4 week program will provide education, information, and strategies for dealing with areas that caregivers may find challenging in their caregiving role. The study will evaluate the effectiveness of the program to decrease the caregiver's stress, strain and burden, increase the caregiver's knowledge of strategies and community services and increase their role satisfaction as a stroke caregiver and quality of life two weeks after the program and 6 months after the program.

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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

Hamilton Health Sciences

Hamilton, Ontario, L8L 2X2, Canada

About this study

The modules in the program are: 1) Program Introduction, sharing Caregiving Stories and an introduction to Self Management; 2) Community Connections; Session 3 and 4 are chosen by the participants during session 1 from 6 possible options: Communication in your relationship; Cognition, Memory and Personhood; Dealing with your Emotions; Managing your Stress; Changing roles in your relationships and How to be Caregiver Smart? The programs provides education, information and strategies to deal with the areas that caregivers struggle with as caregivers in order to help them feel better able to prepared to manage as caregivers. Also, the investigators also hope to develop some beginning understanding of when is the best time to provide the program to stroke caregivers to be most helpful to them in their caregiving role.

Who can participate

Healthy volunteers accepted: No

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

Informal unpaid family stroke caregivers

Inclusion criteria

Informal unpaid family stroke caregivers

  • 18 years of age or older;
  • Have provided care to stroke survivor within the home for at least 2 months;
  • Have the ability to communicate in English;
  • Live within Central South Ontario Stroke Region or the West GTA Stroke Region.

Exclusion criteria

Caregivers who:

  • Paid to provide care;
  • Are friends who provide care to stroke survivor;
  • Are providing palliative care to stroke survivor within the home.

Treatment and study plan

Stroke Caregiver Education and Support Program

Behavioral

4 week program offered weekly over a 4 week period. Each session is a 2 hour small group guided discussion on the topic area facilitated by 2 trained facilitators. The topics are: Program Introduction, sharing Caregiving Stories and an introduction to Self Management; Community Connections; Session 3 and 4 are chosen by the participants during session 1 from 6 possible options: Communication in your relationship; Cognition, Memory and Personhood; Dealing with your Emotions; Managing your Stress; Changing roles in your relationships and How to be Caregiver Smart?

Other names: FICSS Program

Primary outcomes

  1. Change in Baseline Bakas Caregiving Outcome Scale at 2 Weeks and 6 Months post Intervention

    Time frame: Baseline, 2 weeks and 6 months Post Intervention

    12 item self report instrument using a 7 point Likert scale 4 designed to measure changes in post stroke caregiver family life changes in the areas of social functioning, subjective well being and physical health,financial well-being, physical functioning, general health, roles in life and level of energy. The revised scale has demonstrated internal consistency reliability of 0.90 and construct validity of 0.66 5. The scale measures both the positive and negative aspects of caregiving with an emphasis on social consequences.

Secondary outcomes

  1. Change in Baseline Oberst Caregiving Burden Scale at 2 Weeks and 6 Months Post Intervention

    Time frame: Baseline, 2 weeks and 6 months post intervention

    15 item self report instrument using a 5 point Likert scale to evaluate caregiver perceptions of the time and difficulty associated with 15 tasks performed in caring for recovering family members. It has been validated in cancer and stroke caregiver populations. It has demonstrated internal consistency reliability of 0.90 - 0.94 and validity of between 0.61 to 0.82 in stroke caregivers.

  2. Open Ended Focus Group Interview to assess impact of program weeks and 6 months post intervention

    Time frame: 2 weeks and 6 months post Intervention

    The questions will be designed to assess the impact on the stroke caregiver; perceived improvement in problem solving abilities; increased awareness and usage of community services; any indirect influence on the stroke survivor; timing of the intervention; and evaluation of the FICSS project.

  3. Caregiver Baseline/Stroke Survivor Baseline Questionnaire

    Time frame: Baseline

    Caregiver Baseline/Stroke Survivor Baseline Questionnaire is a 26 item questionnaire that collects socio-demographic and health related information of the stroke survivor and caregiver. The questionnaire is an adaptation of the one developed by Dr. Jill Cameron to include socio-demographic and health related information on the stroke survivor. The original questionnaire has been utilized in her initial and ongoing research in her "Timing it Right Framework" for stroke caregivers. Permission has been granted by Dr. Cameron to utilize the questionnaire for the study.

Sponsors and collaborators

Lead sponsor

March of Dimes, Canada

Other

Collaborators

  • Hamilton Health Sciences Corporation

Registry information

Official study title

A Pilot Study of the Evaluation of the Family Informal Caregiver Stroke Self Management (FICSS) Research Project: Impact on Caregiver Psychosocial, Emotional and Health Needs

Acronym: FICSS

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
May 17, 2011
Registry last updated
Mar 16, 2016

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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