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

Self Efficacy Clinical Trial

Official title:

The Effectiveness of the Adapted Bridge's Self-management Programme in South African Community-dwelling Stroke Survivors: A Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03271684
• Other study ID #: BM17/2/7
• Status: Not yet recruiting
• Phase: N/A
• First received: August 31, 2017
• Last updated: September 3, 2017
• Start date: October 1, 2017
• Est. completion date: December 1, 2018

Study information

• Verified date: September 2017
• Source: University of the Western Cape
• Contact: Reham Nasir, MSc
• Phone: +27613756412
• Email: 3608175[@]myuwc.ac.za
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 84
• Est. completion date: December 1, 2018
• Est. primary completion date: June 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Self Efficacy
• Self-Care

Intervention

Other:
• self-management
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
• Control
Participants will receive usual rehabilitation treatment, they will also be given a booklet with education program and exercises they can perform at home.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of the Western Cape

References & Publications (10)

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. Epub 2007 Mar 12. — View 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. — View 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. — View Citation

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. Epub 2003 May 29. — View 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. — View 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. — View Citation

Lennon S, Johnson L. The modified rivermead mobility index: validity and reliability. Disabil Rehabil. 2000 Dec 15;22(18):833-9. — View Citation

McDonnell M. Action research arm test. Aust J Physiother. 2008;54(3):220. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The Rivermead Mobility Index:	is a 15 point index with various topics and questions aimed at objectively determining the participant's mobility level. According to Lennon & Johnson (2000) highly reliable between raters (ICC = 0.98, p < 0.001) with high internal consistency (Cronbach's alpha = 0.93).	baseline to the 6 months after intervention
Secondary	Rivermead Activities of Daily Living Scale:	is a 31 point scale used to determine the level of independence a participant has with self-care and household tasks of varying difficulty. It has an excellent overall test-retest reliability (ICC = 0.96) (Chen et al, 2007) and an excellent concurrent validity at 180 days post stroke (r = 0.93) (Hsueh et al, 2003).	baseline to the 6 months after intervention
Secondary	The Mini-BESTest:	is a 14-item clinical test that covers four components of balance control (anticipatory postural adjustments, postural responses, sensory orientation and stability in gait). Each item is scored from 0 (unable or requiring help) to 2 (normal) and the maximal score is 28 points. The Mini-BESTest has an excellent test-retest reliability (ICC = 0.96), with an excellent convergent validity (r = 0.96) (Godi et al, 2013).	baseline to the 6 months after intervention
Secondary	The Subjective Index of Physical and Social Outcome scale	a 10 point rating index aimed at determining the participants' perceived extent of participation within the community, with its main domains as perceived functioning and social connectedness. SIPSO has been shown to present an excellent test-retest reliability with ICC = 0.96 and has indicated a proven validity (Trigg & Wood, 2003).	baseline to the 6 months after intervention
Secondary	National Institute for Health Stroke Scale	is a 15 item neurologic examination that provides a quantitative measure of stroke-related neurologic deficit. According to Kasner et al, (1999) reliability Agreement between pairs of raters was also very good to excellent, with ICCs ranging from 0.70 to 0.89.	baseline to the 6 months after intervention
Secondary	Action Research Arm Test	is a 19 item scale divided into four subscales: grasp, grip, pinch, and gross movement. The items within each subscale are arranged on a 4-point ordinal scale ranging from 0 to 3, with 3 indicating normal performance on each item. The maximum score on the ARAT is 57 points According to McDonnell, 2008 Inter-rater and retest reliability have been shown to be high (ICC > 0.98) in studies involving patients with stroke and Concurrent validity has been confirmed by comparison with the upper limb component of the Fugl- Meyer Assessment and the Motor Assessment Scale (MAS).	baseline to the 6 months after intervention
Secondary	6-minute walk test	Functional ability will be assessed using the 6-minute walk test (6-MWT), a reliable and valid measure for the stroke population. Participants will be instructed to walk at a comfortable pace on a 30-m measured walkway for 6 minutes. The outcome will be the total distance covered during testing. 6MWT exhibits excellent test-retest reliability (ICC = 0.973; 95 % CI = 0.925 to 0.988), it presents a minimal detectable change of 54.1 m, and an acceptable concurrent validity (r = 0.52 to 0.89) (Fulk et al, 2008).	baseline to the 6 months after intervention