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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03271684
Enrollment
84
Registered
2017-09-05
Start date
2017-10-01
Completion date
2018-12-01
Last updated
2017-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Self-Care, Self Efficacy

Keywords

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

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.

Interventions

OTHERself-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

OTHERControl

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

Sponsors

University of the Western Cape
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

Double-blinded, participant and assessor blinded, randomised trial.

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Stroke Self-Efficacy Questionnaire(SSEQ):baseline to the 6 months after interventionThe 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

Secondary

MeasureTime frameDescription
Rivermead Activities of Daily Living Scale:baseline to the 6 months after interventionis 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).
The Mini-BESTest:baseline to the 6 months after interventionis 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).
The Subjective Index of Physical and Social Outcome scalebaseline to the 6 months after interventiona 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).
The Rivermead Mobility Index:baseline to the 6 months after interventionis 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).
Action Research Arm Testbaseline to the 6 months after interventionis 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).
6-minute walk testbaseline to the 6 months after interventionFunctional 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).
National Institute for Health Stroke Scalebaseline to the 6 months after interventionis 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.

Contacts

Primary ContactReham Nasir, MSc
3608175@myuwc.ac.za+27613756412
Backup ContactAnthea Rhoda, Professor
arhoda@uwc.ac.za+27827757748

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026