Evaluation of the Stroke Caregiver Education and Support Program (FICSS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by March of Dimes, Canada.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Hamilton Health Sciences Corporation
Information provided by:
March of Dimes, Canada
ClinicalTrials.gov Identifier:
NCT01355029
First received: May 13, 2011
Last updated: May 16, 2011
Last verified: April 2011
  Purpose

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.


Condition Intervention
Stroke
Behavioral: Stroke Caregiver Education and Support Program

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official 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

Resource links provided by NLM:


Further study details as provided by March of Dimes, Canada:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • Caregiver Baseline/Stroke Survivor Baseline Questionnaire [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 48
Study Start Date: February 2011
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Stroke Caregiver Education and Support Program
    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 Name: FICSS Program
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01355029

Contacts
Contact: Laura Klaponski, B.Sc. Hs. 416-425-3463 ext 7212 lklaponski@marchofdimes.ca
Contact: Rhonda M Whiteman, MN 905-527-4322 ext 46705 mcnicolr@hhs.ca

Locations
Canada, Ontario
Hamilton Health Sciences Recruiting
Hamilton, Ontario, Canada, L8L 2X2
Principal Investigator: Rhonda M Whiteman, MN         
Sponsors and Collaborators
March of Dimes, Canada
Hamilton Health Sciences Corporation
Investigators
Principal Investigator: Gail Mores, B.Sc. Rec. March of Dimes, Canada
  More Information

No publications provided

Responsible Party: Gail Mores, Director of National and Provincial Programs - Primary Investigator, March of Dimes Canada
ClinicalTrials.gov Identifier: NCT01355029     History of Changes
Other Study ID Numbers: OSN1101-000119, 10-668
Study First Received: May 13, 2011
Last Updated: May 16, 2011
Health Authority: Canada: Ethics Review Committee

Keywords provided by March of Dimes, Canada:
Stroke caregivers
Family Caregivers
Stroke

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on August 21, 2014