The Effectiveness of the Adapted Bridge's Self-management Programme

NCT03271684 | Unknown

• 1 other identifier: BM17/2/7
• Study Type: interventional
• Target: 84
• Locations: 0 countries
• Sites: N/A

Brief Summary

The effectiveness of the adapted Bridge's self-management programme in South African community-dwelling stroke survivors: A randomized controlled trial with two arms will be used, with the intervention group receiving self-management sessions delivered by experienced therapists and usual care and control group will only receive usual care which includes a information booklet.

Conditions

Self-Care; Self Efficacy

Keywords

stroke, self-management, Bridges, participation, function, self-efficacy

Outcome Measures

Primary Outcomes (1)

• Stroke Self-Efficacy Questionnaire(SSEQ):

  The SSEQ is a 13 point questionnaire developed by Jones et al (2008) and is aimed to determine the individuals perceived level of self-efficacy in completing a range of relevant functional tasks, such as walking, getting comfortable in bed, as well as several self-management tasks

  baseline to the 6 months after intervention

Secondary Outcomes (7)

• The Rivermead Mobility Index:

  baseline to the 6 months after intervention

• Rivermead Activities of Daily Living Scale:

  baseline to the 6 months after intervention

• The Mini-BESTest:

  baseline to the 6 months after intervention

• The Subjective Index of Physical and Social Outcome scale

  baseline to the 6 months after intervention

• National Institute for Health Stroke Scale

  baseline to the 6 months after intervention

Study Arms (2)

intervention group

EXPERIMENTAL

Will receive one session of up to one-hour per week over a six-week period in self-management in addition to their usual rehabilitation and workbook.

Other: self-management

control group

OTHER

Will receive booklet consist of home exercises and education besides the usual care

Other: Control

Interventions

self-management OTHER

one session of up to one-hour per week over a six-week period in addition to their usual rehabilitation. During each session strategies will be used to promote specific behaviors that exemplify the hallmarks of self-management. These behaviors include enabling patients to work out ways of taking control of their daily lives by setting small targets, recording their progress and problem-solving. The content of the sessions is determined by the patient and their personal goals rather than being professionally directed

intervention group

Control OTHER

Participants will receive usual rehabilitation treatment, they will also be given a booklet with education program and exercises they can perform at home.

control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• having a first ever stroke, by a physician, based on the WHO (1988) definition of stroke which is "rapidly developing clinical signs of focal (or global) disturbance of cerebral function, with symptoms lasting 24 hours or longer or leading to death, with no apparent cause other than of vascular origin"; ≥18 years of age; of sufficient cognition to participate: having a score of ≥24 points on mini-mental state examination (placing participants at matched mental status) ; are medically stable and; and are within the sub-acute to chronic phase of their rehabilitation (10 weeks to 6-months post stroke).

You may not qualify if:

• Participants will be excluded if they have serious medical conditions such as HIV/AIDS or TB, which could additionally affect the outcomes evaluated in this study. Participants with depression, having recurrent stroke, still receiving in inpatient rehabilitation, with cognitive or receptive language difficulties and are unable to comprehend the intervention will be excluded.

Sponsors & Collaborators

• University of the Western Cape: lead

Related Publications (10)

• Jones F, Partridge C, Reid F. The Stroke Self-Efficacy Questionnaire: measuring individual confidence in functional performance after stroke. J Clin Nurs. 2008 Apr;17(7B):244-52. doi: 10.1111/j.1365-2702.2008.02333.x.

  PMID: 18578800 BACKGROUND

• Lennon S, Johnson L. The modified rivermead mobility index: validity and reliability. Disabil Rehabil. 2000 Dec 15;22(18):833-9. doi: 10.1080/09638280050207884.

  PMID: 11197520 BACKGROUND

• Chen HM, Hsieh CL, Sing Kai Lo, Liaw LJ, Chen SM, Lin JH. The test-retest reliability of 2 mobility performance tests in patients with chronic stroke. Neurorehabil Neural Repair. 2007 Jul-Aug;21(4):347-52. doi: 10.1177/1545968306297864. Epub 2007 Mar 12.

  PMID: 17353463 BACKGROUND

• Hsueh IP, Wang CH, Sheu CF, Hsieh CL. Comparison of psychometric properties of three mobility measures for patients with stroke. Stroke. 2003 Jul;34(7):1741-5. doi: 10.1161/01.STR.0000075295.45185.D4. Epub 2003 May 29.

  PMID: 12775883 BACKGROUND

• Godi M, Franchignoni F, Caligari M, Giordano A, Turcato AM, Nardone A. Comparison of reliability, validity, and responsiveness of the mini-BESTest and Berg Balance Scale in patients with balance disorders. Phys Ther. 2013 Feb;93(2):158-67. doi: 10.2522/ptj.20120171. Epub 2012 Sep 27.

  PMID: 23023812 BACKGROUND

• Trigg R, Wood VA. The Subjective Index of Physical and Social Outcome (SIPSO): a new measure for use with stroke patients. Clin Rehabil. 2000 Jun;14(3):288-99. doi: 10.1191/026921500678119607.

  PMID: 10868724 BACKGROUND

• Kasner SE, Chalela JA, Luciano JM, Cucchiara BL, Raps EC, McGarvey ML, Conroy MB, Localio AR. Reliability and validity of estimating the NIH stroke scale score from medical records. Stroke. 1999 Aug;30(8):1534-7. doi: 10.1161/01.str.30.8.1534.

  PMID: 10436096 BACKGROUND

• McDonnell M. Action research arm test. Aust J Physiother. 2008;54(3):220. doi: 10.1016/s0004-9514(08)70034-5. No abstract available.

  PMID: 18833688 BACKGROUND

• The World Health Organization MONICA Project (monitoring trends and determinants in cardiovascular disease): a major international collaboration. WHO MONICA Project Principal Investigators. J Clin Epidemiol. 1988;41(2):105-14. doi: 10.1016/0895-4356(88)90084-4.

  PMID: 3335877 BACKGROUND

• Fulk GD, Echternach JL, Nof L, O'Sullivan S. Clinometric properties of the six-minute walk test in individuals undergoing rehabilitation poststroke. Physiother Theory Pract. 2008 May-Jun;24(3):195-204. doi: 10.1080/09593980701588284.

  PMID: 18569856 BACKGROUND

MeSH Terms

Conditions

Stroke

Interventions

Self-Management

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Rehabilitation; Health Services; Health Care Facilities Workforce and Services

Central Study Contacts

Reham Nasir, MSc

CONTACT

+27613756412; 3608175@myuwc.ac.za

Anthea Rhoda, Professor

CONTACT

+27827757748; arhoda@uwc.ac.za

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double-blinded, participant and assessor blinded, randomised trial.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: August 31, 2017
• First Posted: September 5, 2017
• Study Start: October 1, 2017
• Primary Completion: June 1, 2018
• Study Completion: December 1, 2018
• Last Updated: September 7, 2017

Record last verified: 2017-09