The NKF-NUS hemodialysis trial protocol - a randomized controlled trial to determine the effectiveness of a self management intervention for hemodialysis patients
<p>Abstract</p> <p>Background</p> <p>Poor adherence to treatment is common in patients on hemodialysis which may increase risk for poor clinical outcomes and mortality. Self management interventions have been shown to be effective in improving compliance in other chroni...
| Main Authors: | , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMC
2011-01-01
|
| Series: | BMC Nephrology |
| Online Access: | http://www.biomedcentral.com/1471-2369/12/4 |
| _version_ | 1828746551562862592 |
|---|---|
| author | Krishnan Deby Seet Penny Mooppil Nandakumar Griva Konstadina James Hayley Newman Stanton P |
| author_facet | Krishnan Deby Seet Penny Mooppil Nandakumar Griva Konstadina James Hayley Newman Stanton P |
| author_sort | Krishnan Deby |
| collection | DOAJ |
| description | <p>Abstract</p> <p>Background</p> <p>Poor adherence to treatment is common in patients on hemodialysis which may increase risk for poor clinical outcomes and mortality. Self management interventions have been shown to be effective in improving compliance in other chronic populations. The aim of this trial is to evaluate the effectiveness of a recently developed group based self management intervention for hemodialysis patients compared to standard care.</p> <p>Methods/Design</p> <p>This is a multicentre parallel arm block randomized controlled trial (RCT) of a four session group self management intervention for hemodialysis patients delivered by health care professionals compared to standard care. A total of 176 consenting adults maintained on hemodialysis for a minimum of 6 months will be randomized to receive the self management intervention or standard care. Primary outcomes are biochemical markers of clinical status and adherence. Secondary outcomes include general health related quality of life, disease-specific quality of life, mood, self efficacy and self-reported adherence. Outcomes will be measured at baseline, immediately post-intervention and at 3 and 9 months post-intervention by an independent assessor and analysed on intention to treat principles with linear mixed-effects models across all time points. A qualitative component will examine which aspects of program participants found particularly useful and any barriers to change.</p> <p>Discussion</p> <p>The NKF-NUS intervention builds upon previous research emphasizing the importance of empowering patients in taking control of their treatment management. The trial design addresses weaknesses of previous research by use of an adequate sample size to detect clinically significant changes in biochemical markers, recruitment of a sufficiently large representative sample, a theory based intervention and careful assessment of both clinical and psychological endpoints at various follow up points. Inclusion of multiple dependent variables allows us to assess the broader impact on the intervention including both hard end points as well as patient reported outcomes. This program, if found to be effective, has the potential to be implemented within the existing renal services delivery model in Singapore, particularly as this is being delivered by health care professionals already working with hemodialysis patients in these settings who are specifically trained in facilitating self management in renal patients.</p> <p>Trial registration</p> <p>Current Controlled Trials <a href="http://www.controlled-trials.com/ISRTN31434033">ISRTN31434033</a></p> |
| first_indexed | 2024-04-14T04:26:42Z |
| format | Article |
| id | doaj.art-d33eb2ac7bc64a1595211965f78e2d33 |
| institution | Directory Open Access Journal |
| issn | 1471-2369 |
| language | English |
| last_indexed | 2024-04-14T04:26:42Z |
| publishDate | 2011-01-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Nephrology |
| spelling | doaj.art-d33eb2ac7bc64a1595211965f78e2d332022-12-22T02:12:16ZengBMCBMC Nephrology1471-23692011-01-01121410.1186/1471-2369-12-4The NKF-NUS hemodialysis trial protocol - a randomized controlled trial to determine the effectiveness of a self management intervention for hemodialysis patientsKrishnan DebySeet PennyMooppil NandakumarGriva KonstadinaJames HayleyNewman Stanton P<p>Abstract</p> <p>Background</p> <p>Poor adherence to treatment is common in patients on hemodialysis which may increase risk for poor clinical outcomes and mortality. Self management interventions have been shown to be effective in improving compliance in other chronic populations. The aim of this trial is to evaluate the effectiveness of a recently developed group based self management intervention for hemodialysis patients compared to standard care.</p> <p>Methods/Design</p> <p>This is a multicentre parallel arm block randomized controlled trial (RCT) of a four session group self management intervention for hemodialysis patients delivered by health care professionals compared to standard care. A total of 176 consenting adults maintained on hemodialysis for a minimum of 6 months will be randomized to receive the self management intervention or standard care. Primary outcomes are biochemical markers of clinical status and adherence. Secondary outcomes include general health related quality of life, disease-specific quality of life, mood, self efficacy and self-reported adherence. Outcomes will be measured at baseline, immediately post-intervention and at 3 and 9 months post-intervention by an independent assessor and analysed on intention to treat principles with linear mixed-effects models across all time points. A qualitative component will examine which aspects of program participants found particularly useful and any barriers to change.</p> <p>Discussion</p> <p>The NKF-NUS intervention builds upon previous research emphasizing the importance of empowering patients in taking control of their treatment management. The trial design addresses weaknesses of previous research by use of an adequate sample size to detect clinically significant changes in biochemical markers, recruitment of a sufficiently large representative sample, a theory based intervention and careful assessment of both clinical and psychological endpoints at various follow up points. Inclusion of multiple dependent variables allows us to assess the broader impact on the intervention including both hard end points as well as patient reported outcomes. This program, if found to be effective, has the potential to be implemented within the existing renal services delivery model in Singapore, particularly as this is being delivered by health care professionals already working with hemodialysis patients in these settings who are specifically trained in facilitating self management in renal patients.</p> <p>Trial registration</p> <p>Current Controlled Trials <a href="http://www.controlled-trials.com/ISRTN31434033">ISRTN31434033</a></p>http://www.biomedcentral.com/1471-2369/12/4 |
| spellingShingle | Krishnan Deby Seet Penny Mooppil Nandakumar Griva Konstadina James Hayley Newman Stanton P The NKF-NUS hemodialysis trial protocol - a randomized controlled trial to determine the effectiveness of a self management intervention for hemodialysis patients BMC Nephrology |
| title | The NKF-NUS hemodialysis trial protocol - a randomized controlled trial to determine the effectiveness of a self management intervention for hemodialysis patients |
| title_full | The NKF-NUS hemodialysis trial protocol - a randomized controlled trial to determine the effectiveness of a self management intervention for hemodialysis patients |
| title_fullStr | The NKF-NUS hemodialysis trial protocol - a randomized controlled trial to determine the effectiveness of a self management intervention for hemodialysis patients |
| title_full_unstemmed | The NKF-NUS hemodialysis trial protocol - a randomized controlled trial to determine the effectiveness of a self management intervention for hemodialysis patients |
| title_short | The NKF-NUS hemodialysis trial protocol - a randomized controlled trial to determine the effectiveness of a self management intervention for hemodialysis patients |
| title_sort | nkf nus hemodialysis trial protocol a randomized controlled trial to determine the effectiveness of a self management intervention for hemodialysis patients |
| url | http://www.biomedcentral.com/1471-2369/12/4 |
| work_keys_str_mv | AT krishnandeby thenkfnushemodialysistrialprotocolarandomizedcontrolledtrialtodeterminetheeffectivenessofaselfmanagementinterventionforhemodialysispatients AT seetpenny thenkfnushemodialysistrialprotocolarandomizedcontrolledtrialtodeterminetheeffectivenessofaselfmanagementinterventionforhemodialysispatients AT mooppilnandakumar thenkfnushemodialysistrialprotocolarandomizedcontrolledtrialtodeterminetheeffectivenessofaselfmanagementinterventionforhemodialysispatients AT grivakonstadina thenkfnushemodialysistrialprotocolarandomizedcontrolledtrialtodeterminetheeffectivenessofaselfmanagementinterventionforhemodialysispatients AT jameshayley thenkfnushemodialysistrialprotocolarandomizedcontrolledtrialtodeterminetheeffectivenessofaselfmanagementinterventionforhemodialysispatients AT newmanstantonp thenkfnushemodialysistrialprotocolarandomizedcontrolledtrialtodeterminetheeffectivenessofaselfmanagementinterventionforhemodialysispatients AT krishnandeby nkfnushemodialysistrialprotocolarandomizedcontrolledtrialtodeterminetheeffectivenessofaselfmanagementinterventionforhemodialysispatients AT seetpenny nkfnushemodialysistrialprotocolarandomizedcontrolledtrialtodeterminetheeffectivenessofaselfmanagementinterventionforhemodialysispatients AT mooppilnandakumar nkfnushemodialysistrialprotocolarandomizedcontrolledtrialtodeterminetheeffectivenessofaselfmanagementinterventionforhemodialysispatients AT grivakonstadina nkfnushemodialysistrialprotocolarandomizedcontrolledtrialtodeterminetheeffectivenessofaselfmanagementinterventionforhemodialysispatients AT jameshayley nkfnushemodialysistrialprotocolarandomizedcontrolledtrialtodeterminetheeffectivenessofaselfmanagementinterventionforhemodialysispatients AT newmanstantonp nkfnushemodialysistrialprotocolarandomizedcontrolledtrialtodeterminetheeffectivenessofaselfmanagementinterventionforhemodialysispatients |