Evaluation of the Stroke Caregiver Education and Support Program (FICSS)
Recruitment status was Recruiting
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.
|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|
- 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.
- 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.
|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)|
Behavioral: Stroke Caregiver Education and Support Program
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01355029
|Contact: Laura Klaponski, B.Sc. Hs.||416-425-3463 ext email@example.com|
|Contact: Rhonda M Whiteman, MN||905-527-4322 ext firstname.lastname@example.org|
|Hamilton Health Sciences||Recruiting|
|Hamilton, Ontario, Canada, L8L 2X2|
|Principal Investigator: Rhonda M Whiteman, MN|
|Principal Investigator:||Gail Mores, B.Sc. Rec.||March of Dimes, Canada|