Clinical trial NCT03271684: The Effectiveness of the Adapted Bridge's Self-management Programme
Official title: The Effectiveness of the Adapted Bridge's Self-management Programme in South African Community-dwelling Stroke Survivors: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Self-Care
Self Efficacy
Keywords: stroke, self-management, Bridges, participation, function, self-efficacy
Lead sponsor: University of the Western Cape
Sponsor class: OTHER
First posted: 2017-09-05
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: This study aim to determine the effectiveness of the Adapted bridges self-management intervention on South African stroke patients' functional activity, self-efficacy, and participation. Method: This experimental study will make use of a randomized controlled design (RCT), consisting of one hundred and sixty eight stroke survivors recruited from different health care facilities within the Cape Metropolitan area. The study participants will be divided randomly into two groups, with one receiving the intervention - the experimental group - and the other receiving an educational booklet - the control group. Participants will be assessed at baseline, immediately post-intervention (six weeks), three and sixth-month post intervention, using standardized outcome measures (both subjective outcome measures and objective clinical tools). Ethical clearance and permission to conduct the study will be obtained and patient information will be kept confidential. Analyses will be conducted using descriptive statistics of frequencies and percentages for categorical variables and mean and standard deviation for continuous variables. Given the assumptions of equal variance, a two-way full factorial ANOVA will be computed in order to assess interaction between groups and intervention type.

Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Stroke Self-Efficacy Questionnaire(SSEQ):
timeFrame: baseline to the 6 months after intervention
Secondary outcomes:
measure: The Rivermead Mobility Index:
timeFrame: baseline to the 6 months after intervention
measure: Rivermead Activities of Daily Living Scale:
timeFrame: baseline to the 6 months after intervention
measure: The Mini-BESTest:
timeFrame: baseline to the 6 months after intervention
measure: The Subjective Index of Physical and Social Outcome scale
timeFrame: baseline to the 6 months after intervention
measure: National Institute for Health Stroke Scale
timeFrame: baseline to the 6 months after intervention
measure: Action Research Arm Test
timeFrame: baseline to the 6 months after intervention
measure: 6-minute walk test
timeFrame: baseline to the 6 months after intervention
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
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citation: 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.
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citation: 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.
citation: 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.
citation: 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.
citation: McDonnell M. Action research arm test. Aust J Physiother. 2008;54(3):220. doi: 10.1016/s0004-9514(08)70034-5. No abstract available.
citation: 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.
citation: 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.