Effect of a Tailored Multidimensional Intervention on the Care Burden Among Family Caregivers of Stroke Survivors

NCT04211662 | Completed

• 1 other identifier: P.0195
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

Family caregivers are the key persons in the recovery and rehabilitation process of stroke survivors. Despite multiple researches recommended the development of interventions which are based on the family caregivers' needs and recommended the conduction of the interventions based on the integration of skill-building, psychoeducation, and peer support to relieve the care burden they feel, there are no studies conducted to evaluate the effect of such these interventions on the family caregivers of stroke survivors in Egypt. The purpose of this study is to evaluate the effect of a tailored multidimensional intervention on the care burden among family caregivers of stroke survivors. Using a randomized control trial, 110 family caregivers will be recruited from the community; from the outpatient clinics and rehabilitation clinics which are located at Mansoura city (Capital of Dakahlia Governorate) and the surrounding cities and villages. The participants will be randomized through 1:1 open-label randomization to the intervention group and the control group. The intervention group will receive the tailored multidimensional intervention. The intervention will last for 6 months. 3 home visits and 3 telephone interventions and 1 peer support will be conducted during the first 3 months. the home visits and telephone interventions will be conducted biweekly alternately. During the second 3 months, 3 telephone follow-ups will be conducted monthly. Regarding the control group, they will receive a simple educational booklet through one home visit. The primary outcome is the care burden (Zarit Burden Interview) and secondary outcomes are the perceived needs (Family Needs Questionnaire-Revised), coping strategies (Brief Coping Orientation to Problems Experienced) and quality of life (World Health Organization Quality of Life-BREF) among family caregivers. The primary and secondary outcomes will be assessed basically before the intervention and after the 3rd and 6th months since the start of the intervention.

Conditions

Stroke; Caregiver Burden; Caregiver Burnout

Keywords

Family caregiver -Stroke - Care burden - Intervention

Outcome Measures

Primary Outcomes (1)

• Measuring the change of the Care burden among family caregivers of stroke survivors (Zarit Burden Interview)

  Care burden can be defined in this context as the personal strain and role strain that the family caregiver experienced due to caring for one of the family. members having stroke. Consequently, the family caregivers will suffer from physical or psychological or emotional or social or financial complains. The Short version (12 items) of Zarit Burden Interview will be used. Items are rated on a 5-point Likert scale from 0 (never) to 4 (almost always). the validated Arabic version will be used.

  baseline, 3 months, 6 months

Secondary Outcomes (3)

• Measuring the change of the perceived needs of family caregivers of stroke survivors (Family Needs Questionnaire- Revised (FNQ-R)

  baseline, 3 months and 6 months

• Measuring the change of the coping strategies among family caregivers of stroke survivors (Brief-COPE (Coping Orientation to Problems Experienced) Inventory)

  baseline, 3 months and 6 months

• Measuring the change of the Quality of Life among family caregivers of stroke survivors (WHOQOL-BREF)

  baseline, 3 months and 6 months

Study Arms (2)

Intervention Group

EXPERIMENTAL

Tailored Multidimensional Intervention

Behavioral: Tailored Multidimensional Intervention. the tailored intervention will be implemented through 6 months using a multidimensional approach (skill building, psychoeducation and peer support).

Control Group

NO INTERVENTION

Regarding the control group, the participants will receive a simple educational booklet through one home visit.

Interventions

Tailored Multidimensional Intervention. the tailored intervention will be implemented through 6 months using a multidimensional approach (skill building, psychoeducation and peer support). BEHAVIORAL

Skill-building can be defined as training the family caregivers the following skills (1) hands-on training in such skills as positioning, transferring and mobility techniques and assistance with activities of daily living; (2) coping strategies and stress management (3) communicating with healthcare professionals. Psycho-education is teaching and provision the family caregivers the knowledge and information regarding stroke (stroke definition, types of stroke, risk factors, prevention of recurrent stroke, medication management, stroke complications and measures for prevention and management of these complications). Besides, family caregivers will be taught and given the knowledge and information regarding managing stroke survivors' emotions and behaviors. Peer support can be defined as engaging the family caregivers of stroke survivors in interactions with their peers for support and exchanging advices and experiences.

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants will be included if they meet the following criteria:
• who is 18 years old or more and
• who is caring for stroke survivors having stroke within 6 months ago and with modified Rankin scale scores equal 3 to 5.

You may not qualify if:

• Family caregivers will be excluded:
• if they have cognitive impairments.
• if their stroke survivors have one of the following conditions: (1) the stroke survivors have other limitations of mobility such as (fracture, dislocation, spinal cord injury, spinal vertebrae injury); and (2) the stroke survivor has terminal stage diseases such as end-stage cancer, end-stage liver disease and end-stage kidney disease or any other end-stage diseases.

Sponsors & Collaborators

• Cairo University: lead
• Hiroshima University: collaborator
• Mansoura University: collaborator

Study Sites (1)

Community based study (from the outpatient clinics and the rehabilitation centers at the community at Mansoura city and surrounding cities and villages within Dakahlia)

Al Mansurah, Dakahlia Governorate, 35511, Egypt

Location

Related Publications (20)

• Abd-Allah F, Khedr E, Oraby MI, Bedair AS, Georgy SS, Moustafa RR. Stroke burden in Egypt: data from five epidemiological studies. Int J Neurosci. 2018 Aug;128(8):765-771. doi: 10.1080/00207454.2017.1420068. Epub 2018 Jan 4.

  PMID: 29258372 BACKGROUND

• Adelman RD, Tmanova LL, Delgado D, Dion S, Lachs MS. Caregiver burden: a clinical review. JAMA. 2014 Mar 12;311(10):1052-60. doi: 10.1001/jama.2014.304.

  PMID: 24618967 BACKGROUND

• Andrew NE, Kilkenny MF, Naylor R, Purvis T, Cadilhac DA. The relationship between caregiver impacts and the unmet needs of survivors of stroke. Patient Prefer Adherence. 2015 Jul 27;9:1065-73. doi: 10.2147/PPA.S85147. eCollection 2015.

  PMID: 26251579 BACKGROUND

• Bachner YG. Preliminary assessment of the psychometric properties of the abridged Arabic version of the Zarit Burden Interview among caregivers of cancer patients. Eur J Oncol Nurs. 2013 Oct;17(5):657-60. doi: 10.1016/j.ejon.2013.06.005. Epub 2013 Jul 15.

  PMID: 23867141 BACKGROUND

• Bakas T, Clark PC, Kelly-Hayes M, King RB, Lutz BJ, Miller EL; American Heart Association Council on Cardiovascular and Stroke Nursing and the Stroke Council. Evidence for stroke family caregiver and dyad interventions: a statement for healthcare professionals from the American Heart Association and American Stroke Association. Stroke. 2014 Sep;45(9):2836-52. doi: 10.1161/STR.0000000000000033. Epub 2014 Jul 17.

  PMID: 25034718 BACKGROUND

• Bedard M, Molloy DW, Squire L, Dubois S, Lever JA, O'Donnell M. The Zarit Burden Interview: a new short version and screening version. Gerontologist. 2001 Oct;41(5):652-7. doi: 10.1093/geront/41.5.652.

  PMID: 11574710 BACKGROUND

• Caro CC, Costa JD, Da Cruz DMC. Burden and Quality of Life of Family Caregivers of Stroke Patients. Occup Ther Health Care. 2018 Apr;32(2):154-171. doi: 10.1080/07380577.2018.1449046. Epub 2018 Mar 26.

  PMID: 29578827 BACKGROUND

• Eames S, Hoffmann T, Worrall L, Read S, Wong A. Randomised controlled trial of an education and support package for stroke patients and their carers. BMJ Open. 2013 May 8;3(5):e002538. doi: 10.1136/bmjopen-2012-002538.

  PMID: 23657469 BACKGROUND

• Frontera WR, Bean JF, Damiano D, Ehrlich-Jones L, Fried-Oken M, Jette A, Jung R, Lieber RL, Malec JF, Mueller MJ, Ottenbacher KJ, Tansey KE, Thompson A. Rehabilitation Research at the National Institutes of Health:: Moving the Field Forward (Executive Summary). Phys Ther. 2017 Apr 1;97(4):393-403. doi: 10.1093/ptj/pzx027.

  PMID: 28499004 BACKGROUND

• Gbiri CA, Olawale OA, Isaac SO. Stroke management: Informal caregivers' burdens and strians of caring for stroke survivors. Ann Phys Rehabil Med. 2015 Apr;58(2):98-103. doi: 10.1016/j.rehab.2014.09.017. Epub 2015 Jan 7.

  PMID: 25752228 BACKGROUND

• Hekmatpou D, Mohammad Baghban E, Mardanian Dehkordi L. The effect of patient care education on burden of care and the quality of life of caregivers of stroke patients. J Multidiscip Healthc. 2019 Mar 20;12:211-217. doi: 10.2147/JMDH.S196903. eCollection 2019.

  PMID: 30936715 BACKGROUND

• Jeong YG, Jeong YJ, Kim WC, Kim JS. The mediating effect of caregiver burden on the caregivers' quality of life. J Phys Ther Sci. 2015 May;27(5):1543-7. doi: 10.1589/jpts.27.1543. Epub 2015 May 26.

  PMID: 26157260 BACKGROUND

• Karagiozi, K., Papastavrou, E., Giaglis, G., Pattakou, V., Kosta-Tsolaki, M., & Papaliagkas, V. (2014). Combined Intervention for Caregivers of Patients with Dementia: A Randomized Controlled Trial. International Journal of Academic Research in Psychology, 1(2), 77-95. https://doi.org/10.6007/IJARP/v1-i2/1203

  BACKGROUND

• Lutz, B. J., & Camicia, M. (2016). Supporting the needs of stroke caregivers across the care continuum. Journal of Clinical Outcomes Management, 23(12), 557-566.

  BACKGROUND

• Shata ZN, Amin MR, El-Kady HM, Abu-Nazel MW. Efficacy of a multi-component psychosocial intervention program for caregivers of persons living with neurocognitive disorders, Alexandria, Egypt: A randomized controlled trial. Avicenna J Med. 2017 Apr-Jun;7(2):54-63. doi: 10.4103/2231-0770.203610.

  PMID: 28469987 BACKGROUND

• Tsai PC, Yip PK, Tai JJ, Lou MF. Needs of family caregivers of stroke patients: a longitudinal study of caregivers' perspectives. Patient Prefer Adherence. 2015 Mar 18;9:449-57. doi: 10.2147/PPA.S77713. eCollection 2015.

  PMID: 25834409 BACKGROUND

• Watanabe A, Fukuda M, Suzuki M, Kawaguchi T, Habata T, Akutsu T, Kanda T. Factors decreasing caregiver burden to allow patients with cerebrovascular disease to continue in long-term home care. J Stroke Cerebrovasc Dis. 2015 Feb;24(2):424-30. doi: 10.1016/j.jstrokecerebrovasdis.2014.09.013. Epub 2014 Dec 12.

  PMID: 25511615 BACKGROUND

• White, C. L., Cantu, A. G., & Trevino, M. M. (2015). Interventions for caregivers of stroke survivors: An update of the evidence. Clinical Nursing Studies, 3(3), 87-95. https://doi.org/10.5430/cns.v3n3p87

  BACKGROUND

• Elsheikh MA, Moriyama M, Rahman MM, Kako M, El-Monshed AH, Zoromba M, Zehry H, Khalil MH, El-Gilany AH, Amr M. Effect of a tailored multidimensional intervention on the care burden among family caregivers of stroke survivors: a randomised controlled trial. BMJ Open. 2022 Feb 15;12(2):e049741. doi: 10.1136/bmjopen-2021-049741.

  PMID: 35168963 DERIVED

• Elsheikh MA, Moriyama M, Rahman MM, Kako M, El-Monshed AH, Zoromba M, Zehry H, Khalil MH, Amr M. Effect of a tailored multidimensional intervention on the care burden among family caregivers of stroke survivors: study protocol for a randomised controlled trial. BMJ Open. 2020 Dec 15;10(12):e041637. doi: 10.1136/bmjopen-2020-041637.

  PMID: 33323445 DERIVED

Related Links

• Marwitz, J. (2000). The Family Needs Questionnaire. The Center for Outcome Measurement in Brain Injury. ( accessed October 29, 2019 ).
• Cardiovascular diseases (CVDs)

MeSH Terms

Conditions

Stroke; Caregiver Burden

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stress, Psychological; Behavioral Symptoms; Behavior

Study Officials

• Mahmoud A Elsheikh, PhD Student

  Hiroshima University

  PRINCIPAL INVESTIGATOR

• Michiko Moriyama, Professor

  Hiroshima University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer, Cairo University & PhD student, Hiroshima University

Model Details: open-label, two-arm Randomized Control Trial (RCT)

Study Record Dates

• First Submitted: December 21, 2019
• First Posted: December 26, 2019
• Study Start: December 27, 2019
• Primary Completion: November 30, 2020
• Study Completion: November 30, 2020
• Last Updated: August 19, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The dataset was submitted to the Dryad repository in February 2020.
• Access Criteria: Open access doi:10.5061/dryad.gf1vhhmm5

Locations

EG (1)