Ignite Creation Date:
2024-05-06 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 12:54 PM
Study NCT ID:
NCT03681821
Status:
COMPLETED
Last Update Posted:
2018-09-24
First Post:
2018-09-14
Brief Title:
Effects of Transtheoretical Model-based Intervention on the Self-management of Patients With an Ostomy
Sponsor:
Central South University
Organization:
Central South University
Study Overview
Official Title:
Effects of Transtheoretical Model-based Intervention on the Self-management of Patients With an Ostomy a Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2018-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Colorectal cancer CRC is one of the most commonly diagnosed cancers worldwide The main treatment approach is radical surgery and the auxiliary treatment may be chemotherapy radiotherapy immunotherapy and other supportive therapies which can increase the resection rate reduce the recurrence rate and improve the survival rate Abdominoperineal resection with an ostomy and the formation of a permanent ostomy continue to be the primary and radical surgical approaches for many patients with rectal cancer which results in the loss of defecation control function
Although ostomy-related surgery is a life-saving procedure in most cases it inevitably elicits some complex and lifelong consequences such as uncontrolled gas and stool emissions disturbed patients body images and effects their social and sexual lives which place heavy pressure on ostomy self-management
Some studies have revealed the various ways that patients lives are affected by their stoma including changes to their quality of life body image and social life requiring coping and practical adjustments Others have shown that not enough attention has been paid to patients self-management abilities with most care being provided by nurses or caregivers leaving little opportunities for patients to manage on their own Consequently their self-management ability after discharge remains weak especially their related knowledge and skills Studies have shown that 330-804 of patients with an ostomy cannot cope with the problems encountered in ostomy care
Many scholars focused on the ability of early self-management in patients with an ostomy after discharge and there were several issues in the field of stoma nursing care such as insufficient discharge preparedness because of shortened hospital stays and a lack of systematic acquisition of related knowledge and skills Others highlighted the paucity of attention paid to the post-discharge needs of patients with a stoma and a lack of formal training for follow-up
Currently self-management programs for patients with an ostomy mainly focus on the passive problem-solving model led by nurses and less emphasize has been placed on the self-assessment of patients who passively accept relevant knowledge and skills This is insufficient for the pertinence continuity operability and promotion of self-management It is essential to call for a patient-tailored and theoretical approach to improve self-management and promote rehabilitation
The transtheoretical model TTM is an empirically validated model of individual behavioral change which involves progress through a series of stages to make a particular behavioral change TTM-based interventions have been applied to facilitate health behavioral changes such as physical exercise smoking cessation and weight management studies of which continue to demonstrate positive effects There have been few studies of patients with an ostomy using TTM as an interventional tool to provide continuous and dynamic education Therefore this study decided to investigate the use of an integrated method of incorporating TTM into patient instruction and to provide assistance to enhance the self-management ability of patients with an ostomy
The aim of this study was to determine the effects of a transtheoretical model TTM-based intervention on ostomy self-management on patients stages of change processes of change decisional balance and self-efficacy The studys hypotheses were 1 There would be no significant difference between the intervention group and the control group before the intervention and after intervention there would be more patients in the intervention group than those in the control groups 2 Patients in the intervention group would achieve greater improvement in the ability of self-management than those in the control group
This study was a randomized controlled trial according to the CONSORT guidelines The sample comprised 55 men and 37 women 24 to 77 years old mean standard deviation 528 1113 years The study settings included three tertiary hospitals in Changsha Hunan China The 92 patients recruited were randomized into a control group and an intervention group Instruments including self-management behaviors were assessed at the baseline 2 days before discharge and after 1- 3- and 6-month follow-up The chi-squared test independent sample t test and repeated-measures analysis of variance were used to analyze the data
Although ostomy-related surgery is a life-saving procedure in most cases it inevitably elicits some complex and lifelong consequences such as uncontrolled gas and stool emissions disturbed patients body images and effects their social and sexual lives which place heavy pressure on ostomy self-management
Some studies have revealed the various ways that patients lives are affected by their stoma including changes to their quality of life body image and social life requiring coping and practical adjustments Others have shown that not enough attention has been paid to patients self-management abilities with most care being provided by nurses or caregivers leaving little opportunities for patients to manage on their own Consequently their self-management ability after discharge remains weak especially their related knowledge and skills Studies have shown that 330-804 of patients with an ostomy cannot cope with the problems encountered in ostomy care
Many scholars focused on the ability of early self-management in patients with an ostomy after discharge and there were several issues in the field of stoma nursing care such as insufficient discharge preparedness because of shortened hospital stays and a lack of systematic acquisition of related knowledge and skills Others highlighted the paucity of attention paid to the post-discharge needs of patients with a stoma and a lack of formal training for follow-up
Currently self-management programs for patients with an ostomy mainly focus on the passive problem-solving model led by nurses and less emphasize has been placed on the self-assessment of patients who passively accept relevant knowledge and skills This is insufficient for the pertinence continuity operability and promotion of self-management It is essential to call for a patient-tailored and theoretical approach to improve self-management and promote rehabilitation
The transtheoretical model TTM is an empirically validated model of individual behavioral change which involves progress through a series of stages to make a particular behavioral change TTM-based interventions have been applied to facilitate health behavioral changes such as physical exercise smoking cessation and weight management studies of which continue to demonstrate positive effects There have been few studies of patients with an ostomy using TTM as an interventional tool to provide continuous and dynamic education Therefore this study decided to investigate the use of an integrated method of incorporating TTM into patient instruction and to provide assistance to enhance the self-management ability of patients with an ostomy
The aim of this study was to determine the effects of a transtheoretical model TTM-based intervention on ostomy self-management on patients stages of change processes of change decisional balance and self-efficacy The studys hypotheses were 1 There would be no significant difference between the intervention group and the control group before the intervention and after intervention there would be more patients in the intervention group than those in the control groups 2 Patients in the intervention group would achieve greater improvement in the ability of self-management than those in the control group
This study was a randomized controlled trial according to the CONSORT guidelines The sample comprised 55 men and 37 women 24 to 77 years old mean standard deviation 528 1113 years The study settings included three tertiary hospitals in Changsha Hunan China The 92 patients recruited were randomized into a control group and an intervention group Instruments including self-management behaviors were assessed at the baseline 2 days before discharge and after 1- 3- and 6-month follow-up The chi-squared test independent sample t test and repeated-measures analysis of variance were used to analyze the data
Detailed Description:
The study was a single blind follow-up randomized controlled trial Researchers recruited subjects from three Central South University-affiliated general tertiary hospitals in Changsha Hunan province China And the whole trail was on the basis of the CONSORT statements These three hospitals provided similar conventional care for patients with an ostomy Study procedures were approved by the institutional review boards of all participating centers before data collection began All patients were screened by researchers for eligibility and then enrolled in the study if eligible and if the provided consent
Potential eligible participants were identified by researchers according to medical records at the colorectal surgery unit in each hospital They were recruited with informed consent and researchers explained the study purposes procedures benefits and risks involved orally The participants were then randomly allocated to the intervention or the control group according to a computer-generated block randomization list A sequentially numbered and opaque sealed envelope system was used by a non-investigator
The generated random numbers were put into consecutively numbered and opaque sealed envelopes When enrolling and randomising a new participant the enrolling investigators opened the sealed envelope after participants name was written on next available envelopes the enrolling investigators were blinded to the trial design and study hypotheses
Patients in the intervention group had access to conventional care in addition to receiving the follow-up TTM-based intervention sessions The intervention was provided by trained nurses including one researcher and one enterostomal therapy ET nurse The researcher was regarded as primary leader of the intervention sessions The leader informed patients of the schedule for each session using the educational manualAll can do the same a pro-change program for self-management of an ostomy developed by psychologists nursing managers experienced ET nurses and researchers
Sessions were held in the meeting room in the unit four times at baseline T0 2 days before discharge T1 and at 1-month T2 and 3-months T3 after discharge according to the assessment of their current stage of change delivered by filling the Stages of Change Subscale
No interventions were performed for the control group participants during the study However these patients received conventional care in the colorectal surgery units according to the three hospitals similar nursing guidelines Preoperative visits for brief psychological counseling and general postoperative health education for ostomy cleaning stoma appliance use and self-care skills were provided by ward nurses Additionally post-discharge telephone follow-up focused on an unstructured interview and general health inquiries To minimize contamination bias the health education was implemented to avoid simultaneous scheduling for the two groups
Data were collected by a research assistant who was blind to the study design and allocation of participants At baseline before randomization socio-demographic and clinical characteristics were collected from medical records and personal interviews The two groups of participants completed surveys after each follow-up via face to face interviews at baseline T0 2 days before discharge T1 and at 1-month T2 and 3-months T3 after discharge The last evaluation of scales was performed at 6-months T4 of follow-up via telephone contact
Potential eligible participants were identified by researchers according to medical records at the colorectal surgery unit in each hospital They were recruited with informed consent and researchers explained the study purposes procedures benefits and risks involved orally The participants were then randomly allocated to the intervention or the control group according to a computer-generated block randomization list A sequentially numbered and opaque sealed envelope system was used by a non-investigator
The generated random numbers were put into consecutively numbered and opaque sealed envelopes When enrolling and randomising a new participant the enrolling investigators opened the sealed envelope after participants name was written on next available envelopes the enrolling investigators were blinded to the trial design and study hypotheses
Patients in the intervention group had access to conventional care in addition to receiving the follow-up TTM-based intervention sessions The intervention was provided by trained nurses including one researcher and one enterostomal therapy ET nurse The researcher was regarded as primary leader of the intervention sessions The leader informed patients of the schedule for each session using the educational manualAll can do the same a pro-change program for self-management of an ostomy developed by psychologists nursing managers experienced ET nurses and researchers
Sessions were held in the meeting room in the unit four times at baseline T0 2 days before discharge T1 and at 1-month T2 and 3-months T3 after discharge according to the assessment of their current stage of change delivered by filling the Stages of Change Subscale
No interventions were performed for the control group participants during the study However these patients received conventional care in the colorectal surgery units according to the three hospitals similar nursing guidelines Preoperative visits for brief psychological counseling and general postoperative health education for ostomy cleaning stoma appliance use and self-care skills were provided by ward nurses Additionally post-discharge telephone follow-up focused on an unstructured interview and general health inquiries To minimize contamination bias the health education was implemented to avoid simultaneous scheduling for the two groups
Data were collected by a research assistant who was blind to the study design and allocation of participants At baseline before randomization socio-demographic and clinical characteristics were collected from medical records and personal interviews The two groups of participants completed surveys after each follow-up via face to face interviews at baseline T0 2 days before discharge T1 and at 1-month T2 and 3-months T3 after discharge The last evaluation of scales was performed at 6-months T4 of follow-up via telephone contact
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None