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Trial record 13 of 14 for:    15761078 [PUBMED-IDS]

Effects of Transtheoretical Model-based Intervention on the Self-management of Patients With an Ostomy

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ClinicalTrials.gov Identifier: NCT03681821
Recruitment Status : Completed
First Posted : September 24, 2018
Last Update Posted : September 24, 2018
Sponsor:
Information provided by (Responsible Party):
Shali Wen, Central South University

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 33.0-80.4% 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 study's 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 = 52.8 ± 11.13 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.


Condition or disease Intervention/treatment Phase
Self-management Self Efficacy Behavioral: Transtheoretical Model (TTM)-based Intervention Not Applicable

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 participant's 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 manual'All 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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 94 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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 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 manual 'we all can do the same: a pro-change program for self-management of an ostomy' (developed by psychologists, nursing managers, experienced ET nurses, and researchers).

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.

Masking: Double (Participant, Outcomes Assessor)
Masking Description: 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. 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 participant's name was written on next available envelopes. A sequentially numbered and opaque , sealed envelope system was used by a non-investigator. Additionally, all data collection was conducted by another research assistant who was blind to the study design and allocation of participants.
Primary Purpose: Supportive Care
Official Title: Effects of Transtheoretical Model-based Intervention on the Self-management of Patients With an Ostomy: a Randomized Controlled Trial
Actual Study Start Date : August 1, 2012
Actual Primary Completion Date : September 30, 2012
Actual Study Completion Date : March 31, 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ostomy

Arm Intervention/treatment
Experimental: The intervention group
Patients in the intervention group receiving the follow-up TTM-based intervention sessions.
Behavioral: Transtheoretical Model (TTM)-based Intervention
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 ET nurse. 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. Each face-to-face group contact lasted about 1 hour, depending on the complexity of the patients' problems.

No Intervention: The control group
No interventions except conventional care were performed for the control group.



Primary Outcome Measures :
  1. Change from baseline the stages of change at 3 months [ Time Frame: 3-months (T3) after discharge ]

    There were four subscales in the study, the stages of change subscale, the processes of change subscale, the decisional balance subscale, and the self-efficacy subscale.

    The outcome 1 was measured by the stages of change subscale and aimed to determine changes from baseline the percentage of participants of stages of change at 3 months. This subscale consisted of one item: 'Would you participant in self-management behavior of ostomy regularly?), which assess the patients' stages of self-management behavioral change, with five statements representing each stage: precontemplation, contemplation, preparation, action, and maintenance. Patients were asked to select one suitable statement that exactly described their current condition of ostomy self-management .


  2. Change from baseline the scores of the processes of change at 3 months [ Time Frame: 3-months (T3) after discharge ]
    The outcome 2 was measured by the stages of change subscale and aimed to determine changes from baseline the scores of the processes of change subscale at 3 months. This subscale was used to assess whether patients have had any activities or experiences that can affect their self-management of ostomy. It comprised 23 items and two dimensions, including cognitive level and behavioral level. Each individual item was scored from 1 (never) to 5 (always), with higher scores indicating higher frequency use of the process. The Cronbach values of the two dimensions were 0.958 and 0.905 respectively.

  3. Change from baseline the scores of decisional balance at 3 months [ Time Frame: 3-months (T3) after discharge ]
    The outcome 3 was measured by the stages of change subscale and aimed to determine changes from baseline the scores of decisional balance subscale at 3 months. This subscale was developed to assess patients' various points of view on the method of ostomy self-management that they had undertaken. It covered two dimensions of 20 items including perceived benefits and perceived barriers. Each item was ranked on a five-point Likert scale ranging from 1 (absolutely disagree) to 5 (absolutely agree). A higher score indicates a greater degree of agreement. The Cronbach's value of the perceived benefits and perceived barriers were 0.895 and 0.717, respectively.

  4. Change from baseline the scores of self-efficacy at 3 months [ Time Frame: 3-months (T3) after discharge ]
    The outcome 4 was measured by the stages of change subscale and aimed to determine changes from baseline the scores of self-efficacy subscale at 3 months. The scale consisted of eight items and aimed to assess patients' confidence in self-management. Each item is evaluated on a Likert-type scale (1-5). A higher score indicated stronger self-confidence. In this study, the Cronbach's coefficient level of the scale was 0.966 .



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Had received surgical treatment with a permanent ostomy for the first time;
  • Must be Conscious, with normal communication ability;
  • Must be volunteered to join the study.

Exclusion Criteria:

  • Share a hospital room with a current study participant;
  • With other types of cancer;
  • Alcoholics and/or drug addicts;
  • Disabilities and cannot take care of themselves
  Study Documents (Full-Text)

Documents provided by Shali Wen, Central South University:
Informed Consent Form  [PDF] December 31, 2011


Publications of Results:

Other Publications:
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Responsible Party: Shali Wen, Principal investigator, Central South University
ClinicalTrials.gov Identifier: NCT03681821     History of Changes
Other Study ID Numbers: JLI
First Posted: September 24, 2018    Key Record Dates
Last Update Posted: September 24, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The process of data collection cost a lot of human and material resources, some of the data was privacy information of participants, and so on. Considering this, it is improper to share these data.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shali Wen, Central South University:
ostomy
self-management
self-efficacy
health-promoting behavior