Self-CareNCT03271684
The Effectiveness of the Adapted Bridge's Self-management Programme
A study testing self-management in people with Self-Care and Self Efficacy, run by University of the Western Cape.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Self-Care, Self Efficacy
- What is being tested?
- self-management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2017to 1 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effectiveness of the Adapted Bridge's Self-management Programme in South African Community-dwelling Stroke Survivors: A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Self-Care, Self Efficacy
- Being tested
- self-management, Control
- Keywords
- stroke, self-management, Bridges, participation, function, self-efficacy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
self-managementOther
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
ControlOther
Participants will receive usual rehabilitation treatment, they will also be given a booklet with education program and exercises they can perform at home.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: self-management |
| control group | Other | Will receive booklet consist of home exercises and education besides the usual care Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline to the 6 months after intervention
Secondary outcomes (7)
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).
Measured: baseline to the 6 months after intervention
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).
Measured: baseline to the 6 months after intervention
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).
Measured: baseline to the 6 months after intervention
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).
Measured: baseline to the 6 months after intervention
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.
Measured: baseline to the 6 months after intervention
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).
Measured: baseline to the 6 months after intervention
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).
Measured: baseline to the 6 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2017
- Study start1 Oct 2017 (estimated)
- Primary completion1 Jun 2018 (estimated)
- Study completion1 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Self-CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of the Western Cape
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reham Nasir, University of the Western Cape
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03271684
- Sponsor's protocol ID
- BM17/2/7
- Status last verified
- Sep 2017
- First submitted
- 31 Aug 2017
- Last updated
- 7 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Currently not allowed by ethic to share the data with other researchers
Publications
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.
PubMed 18578800Lennon S, Johnson L. The modified rivermead mobility index: validity and reliability. Disabil Rehabil. 2000 Dec 15;22(18):833-9. doi: 10.1080/09638280050207884.
PubMed 11197520Chen 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.
PubMed 17353463Hsueh 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.
PubMed 12775883Godi 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.
PubMed 23023812Trigg 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.
PubMed 10868724Kasner 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.
PubMed 10436096McDonnell M. Action research arm test. Aust J Physiother. 2008;54(3):220. doi: 10.1016/s0004-9514(08)70034-5. No abstract available.
PubMed 18833688The 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.
PubMed 3335877Fulk 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.
PubMed 18569856
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of the Adapted Bridge's Self-management Programme in South African Community-dwelling Stroke Survivors: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03271684
- Acronym / sponsor ID
- BM17/2/7
- Conditions
- Self-Care, Self Efficacy
- Keywords
- stroke, self-management, Bridges, participation, function, self-efficacy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- University of the Western CapeUniversity, hospital or other
- Study start
- 1 Oct 2017 (estimated)
- Primary completion
- 1 Jun 2018 (estimated)
- Study completion
- 1 Dec 2018 (estimated)
- First posted
- 5 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Other: self-managementWill 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. |
| control group | Other | Other: ControlWill receive booklet consist of home exercises and education besides the usual care |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| self-managementone 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 | Other | intervention group |
| ControlParticipants will receive usual rehabilitation treatment, they will also be given a booklet with education program and exercises they can perform at home. | Other | control group |
Primary outcome
Stroke Self-Efficacy Questionnaire(SSEQ):
Time frame: baseline to the 6 months after intervention
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
7 secondary outcomes
The Rivermead Mobility Index:
Time frame: baseline to the 6 months after intervention
Rivermead Activities of Daily Living Scale:
Time frame: baseline to the 6 months after intervention
The Mini-BESTest:
Time frame: baseline to the 6 months after intervention
The Subjective Index of Physical and Social Outcome scale
Time frame: baseline to the 6 months after intervention
National Institute for Health Stroke Scale
Time frame: baseline to the 6 months after intervention
Action Research Arm Test
Time frame: baseline to the 6 months after intervention
6-minute walk test
Time frame: baseline to the 6 months after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2017.
- Background: PubMed 18578800Jones 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.
- Background: PubMed 11197520Lennon S, Johnson L. The modified rivermead mobility index: validity and reliability. Disabil Rehabil. 2000 Dec 15;22(18):833-9. doi: 10.1080/09638280050207884.
- Background: PubMed 17353463Chen 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.
- Background: PubMed 12775883Hsueh 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.
- Background: PubMed 23023812Godi 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.
- Background: PubMed 10868724Trigg 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.
- Background: PubMed 10436096Kasner 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.
- Background: PubMed 18833688McDonnell M. Action research arm test. Aust J Physiother. 2008;54(3):220. doi: 10.1016/s0004-9514(08)70034-5. No abstract available.
- Background: PubMed 3335877The 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.
- Background: PubMed 18569856Fulk 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.
- Individual participant dataSharing planned: Undecided. Currently not allowed by ethic to share the data with other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing self-management in people with Self-Care and Self Efficacy, run by University of the Western Cape.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Reham Nasir, MSc (+27613756412, 3608175@myuwc.ac.za), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stroke Self-Efficacy Questionnaire(SSEQ): (time frame: baseline to the 6 months after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03271684, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2017.