Quality of LifeNCT04943822
The Effectiveness of APP Intervention on Home Self-care Ability and Quality of Life of Patients With Intestinal Stoma
A study testing A new APP in people with Quality of Life and Mobile Apps, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Colorectal cancer is the third leading cause of cancer-related deaths in Taiwan. In the United States, colorectal cancer is the third most common cancer diagnosis and mortality. According to the databases of the Bureau of National Health Insurance (BNHI), in 2003-2006, a total of 15,805 patients with colorectal… Read more about this study
- Who is it for?
- Ages 20 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Quality of Life, Mobile Apps, Ostomy
- What is being tested?
- A new APP
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Sep 2021to 31 Dec 2023
- 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 20 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- diagnosed with primary colorectal cancer;
- at least 20 years of age;
- able to read and speak Mandarin;
- own a smartphone and willingness to use the mobile app after discharge The exclusion criteria
- 1.having other types of cancer; 2.having visual, hearing and/or cognitive impairments/mental disorders; 3.alcohol or drug abuse; 4.dying or having any surgical complications.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Hsing Fang Ko
Kaohsiung City
Hsing Fang Ko, 886-975268525, fung0803@cgmh.org.tw
About this study
Official title: Kaohsiung Chang Gung Memorial Hospital Nursing Department
Colorectal cancer is the third leading cause of cancer-related deaths in Taiwan.
In the United States, colorectal cancer is the third most common cancer diagnosis and mortality.
Read more
According to the databases of the Bureau of National Health Insurance (BNHI), in 2003-2006, a total of 15,805 patients with colorectal surgery were included, and 27.11% were treated with ostomy, while 90.45% were colostomy and 9.55% were ileostomy.
The domestic and foreign researches related to enterostomy mostly use cross-sectional research methods. The quality of life, knowledge of self-care and self-care needs of different postoperative methods of colorectal cancer have not been specifically improved for patients with enterostomy. The research on self-care ability and quality of life is for reference. In other countries, enterostomy care has gradually moved from medical institutions to community care, but community nurses generally have no relevant care skills. Advances in mobile technology such as smartphones and other mobile applications have created more opportunities for individuals to receive health-related treatments, anytime, anywhere and anywhere. In the United States, 93% of adult gastroenterology patients have smartphones in medical teaching hospitals, and most of them are interested in using health-related applications. In addition, previous studies have shown the potential benefits and efficacy of mobile devices for self-care patients in diabetes, obesity and cancer. However, there are limited studies on the feasibility and effectiveness of mobile applications for enterostomy care. Researchers want to explore the effectiveness of mobile device intervention on home self-care ability and quality of life of patients with intestinal stoma.
Read the detailed description
- Background and research purpose Colorectal cancer has been ranked first in the nation's cancer incidence for 11 consecutive years. Clinically, the surgical treatment of rectal cancer is more difficult than that of colorectal cancer. On the one hand, it is the anatomical location factor. Unlike colorectal cancer, which is located in the abdominal cavity, rectal cancer is located in the narrower pelvic cavity with many bones surrounding it. In particular, the pelvic cavity of men is smaller than that of women, so the space available for surgery is relatively smaller than that of the large intestine. Cancer is much less. On the other hand is the consideration of preserving the anus. When removing a tumor that grows in the colon, there is basically no question of whether to preserve the anus or not, because the large intestine is very long. However, in order to clean the tumor, the doctor will leave a certain safe distance between the front and rear ends of the tumor, that is, an extra 5-10 cm of cut. However, for rectal tumors, most clinically patients want to preserve the anus. Therefore, the current safe distance from the end of the tumor during rectal cancer resection is best to exceed 1 cm. Therefore, for patients with rectal cancer, the way of defecation will definitely change after surgery, but the impact will be large or small. It is generally recommended to adjust the diet, such as reducing the intake of fiber such as fruits and vegetables to reduce bowel movements. Some patients think that the uncertainty of dietary restrictions and defecation will affect the quality of life, and they choose permanent artificial anus. Although patients with colorectal cancer usually do not need to remove the anus, they sometimes need temporary artificial anus, such as obstructive colorectal cancer. , First do a temporary artificial anus to help defecation, the purpose is to reduce pressure, let the swollen belly disappear, and then perform surgery to remove the tumor and remove the artificial anus. Although this artificial anus is only temporary, it is not permanent. Among them, about 21% to 70% of enterostomy patients will have some types of complications. These complications are related to stoma dysfunction, insufficient stoma positioning and poor self-care ability. It may cause dermatitis, bleeding, prolapse, necrosis, hernia, edema, waste including leakage, tracheal hernia, stenosis and retraction. Nowadays, advances in mobile technology, such as mobile applications such as smartphones, have created more opportunities for individuals to treat health-related treatments, anytime, anywhere.
- Research motivation The use of apps as a tool for teaching, nursing and diagnosing skin lesions is a very innovative tool that allows learners to generate interest and motivation to learn more, because the use of apps on mobile devices in the health care sector is higher than that of books. Out of 45%-85%. The purpose of this study is to investigate the effectiveness of using mobile devices to intervene in the self-care ability and quality of life of patients with intestinal stoma.
- Research design and objects A single blind-experimental design is adopted. First, those who meet the acceptance criteria and are willing to participate in the research are selected and assigned to the experimental and control groups by random assignment by the computer random number table. It is estimated that 2 people will be needed Nursing staff were admitted in the rectal anal treatment room. Participants were randomly assigned to receive routine discharge care and mobile device guidance or routine outpatient follow-up. Data were collected before the patient was discharged, 1 month, 2 months and 4 months after discharge . The structured questionnaire is filled in by the patient or the researcher.
- statistical methods Descriptive statistics, including frequency distribution and percentage, average and standard deviation, median and interquartile range, and other data to describe the distribution of data; first use the Kolmogorov-Smirnov test to determine whether the data conform to normality Distribution; univariate analysis adopts independent-sample t test or Mann-Whitney U test to compare the difference between the experimental group and the control group in the continuous variables collected, Chi-square test (chi-square test) or Fisher's exact test (Fisher's exact test) compares the difference between the categorical variables collected in the experimental group and the control group; further, binary logistic regression and stepwise regression are used. Regression screening mode method is used to analyze multiple variables to find out the important explanatory factors related to the involvement of mobile devices in personal attributes, self-care ability and quality of life.
- Conditions
- Quality of Life, Mobile Apps, Ostomy
- Being tested
- A new APP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A new APPOther
A new APP for prevention and treatment of complications of intestinal peristomal skin
| Study group | Role | What they receive |
|---|---|---|
| conventional education service program | Placebo comparator | Including the written and verbal health education on preoperative preparation, stoma surgery and postoperative stoma care. At discharge, ET nurses offered teaching information and support for patients, including selection of pouching appliances, drug instructions, health education At each outpatient follow-up, both stomas and patients needed to be assessed. The condition of stoma and peristomal skin, nature and volume of effluent, date of pouch appliances and stoma complications were recorded by ET nurses. Receives: Other: A new APP |
| mobile care device | Experimental | The participants in the intervention group were given the same routine care as the control group pre- and postoperatively. ET nurses taught patients and their family members how to use the home care mobile app before discharge. The home care mobile app was designed and developed for the discharged stoma patients by the research team and an information technology company in March 2021. Patients could receive stoma care from ET nurses through this mobile app at home, not just going to an outpatient clinic. The Major function modules of this mobile app were as follows: (a) appointment: The app users were able to complete the basic personal and medical information and make an appointment with the ET nurse; (b) photograph diagnosis: The ET nurses could make a diagnosis based on the patients' uploaded stoma photographs; and (c) consultation: Patients were able to contact their ET nurses for help and support. This mobile app was used to supplement the outpatient follow-up. Receives: Other: A new APP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life improvement
The Enterostomy- QOL was comprised of 30 questionnaires, it covered seven domains: relations with family and friends, Sleep, activity, sexual activity, social relationship, physiology and psychology. The responses rated on a4-point scale Likert scale (1: extremely, 2: quite a lot, 3: somewhat, 4: not at all). The possible scores range was from 37 to 148. Higher scores indicated that patient had a higher level of quality of life.
Measured: One and a half years
Secondary outcomes (3)
Self-care ability improvement
Assessment scale of self-care ability of enterostomy care was a quantitative scale for nursing staff to evaluate self-care skills in patients with enterostomy. It consisted of 7 items related to: Prepare items, removing the pouching system, measuring the enterostomy diameter, adjusting the size of the enterostomy diameter in a new stoma appliance, skin care, fitting a new enterostomy appliance, and emptying procedure. Each skill was rated on a 4-point scale: Likert scale (1: not at all, 2: some, 3: quite a lot, 4: very much).
Measured: One and a half years
hospital medical record for clinical data
Clinical data including disease, stoma site and type were collected from hospital medical records.
Measured: One and a half years
Stoma complications
It contained mucocutaneous separation, stoma necrosis, peristomal dermatitis, retraction, prolapsed, stenosis and parastomal hernia
Measured: One and a half years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2021
- Study start1 Sep 2021
- Primary completion31 Jul 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04943822
- Sponsor's protocol ID
- fung
- Status last verified
- Jun 2022
- First submitted
- 9 Jun 2021
- Last updated
- 16 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kaohsiung Chang Gung Memorial Hospital Nursing Department
- ClinicalTrials.gov ID
- NCT04943822
- Acronym / sponsor ID
- fung
- Conditions
- Quality of Life, Mobile Apps, Ostomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 31 Jul 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 29 Jun 2021 (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.
Colorectal cancer is the third leading cause of cancer-related deaths in Taiwan.
In the United States, colorectal cancer is the third most common cancer diagnosis and mortality.
According to the databases of the Bureau of National Health Insurance (BNHI), in 2003-2006, a total of 15,805 patients with colorectal surgery were included, and 27.11% were treated with ostomy, while 90.45% were colostomy and 9.55% were ileostomy.
The domestic and foreign researches related to enterostomy mostly use cross-sectional research methods. The quality of life, knowledge of self-care and self-care needs of different postoperative methods of colorectal cancer have not been specifically improved for patients with enterostomy. The research on self-care ability and quality of life is for reference. In other countries, enterostomy care has gradually moved from medical institutions to community care, but community nurses generally have no relevant care skills. Advances in mobile technology such as smartphones and other mobile applications have created more opportunities for individuals to receive health-related treatments, anytime, anywhere and anywhere. In the United States, 93% of adult gastroenterology patients have smartphones in medical teaching hospitals, and most of them are interested in using health-related applications. In addition, previous studies have shown the potential benefits and efficacy of mobile devices for self-care patients in diabetes, obesity and cancer. However, there are limited studies on the feasibility and effectiveness of mobile applications for enterostomy care. Researchers want to explore the effectiveness of mobile device intervention on home self-care ability and quality of life of patients with intestinal stoma.
Detailed description
- Background and research purpose Colorectal cancer has been ranked first in the nation's cancer incidence for 11 consecutive years. Clinically, the surgical treatment of rectal cancer is more difficult than that of colorectal cancer. On the one hand, it is the anatomical location factor. Unlike colorectal cancer, which is located in the abdominal cavity, rectal cancer is located in the narrower pelvic cavity with many bones surrounding it. In particular, the pelvic cavity of men is smaller than that of women, so the space available for surgery is relatively smaller than that of the large intestine. Cancer is much less. On the other hand is the consideration of preserving the anus. When removing a tumor that grows in the colon, there is basically no question of whether to preserve the anus or not, because the large intestine is very long. However, in order to clean the tumor, the doctor will leave a certain safe distance between the front and rear ends of the tumor, that is, an extra 5-10 cm of cut. However, for rectal tumors, most clinically patients want to preserve the anus. Therefore, the current safe distance from the end of the tumor during rectal cancer resection is best to exceed 1 cm. Therefore, for patients with rectal cancer, the way of defecation will definitely change after surgery, but the impact will be large or small. It is generally recommended to adjust the diet, such as reducing the intake of fiber such as fruits and vegetables to reduce bowel movements. Some patients think that the uncertainty of dietary restrictions and defecation will affect the quality of life, and they choose permanent artificial anus. Although patients with colorectal cancer usually do not need to remove the anus, they sometimes need temporary artificial anus, such as obstructive colorectal cancer. , First do a temporary artificial anus to help defecation, the purpose is to reduce pressure, let the swollen belly disappear, and then perform surgery to remove the tumor and remove the artificial anus. Although this artificial anus is only temporary, it is not permanent. Among them, about 21% to 70% of enterostomy patients will have some types of complications. These complications are related to stoma dysfunction, insufficient stoma positioning and poor self-care ability. It may cause dermatitis, bleeding, prolapse, necrosis, hernia, edema, waste including leakage, tracheal hernia, stenosis and retraction. Nowadays, advances in mobile technology, such as mobile applications such as smartphones, have created more opportunities for individuals to treat health-related treatments, anytime, anywhere.
- Research motivation The use of apps as a tool for teaching, nursing and diagnosing skin lesions is a very innovative tool that allows learners to generate interest and motivation to learn more, because the use of apps on mobile devices in the health care sector is higher than that of books. Out of 45%-85%. The purpose of this study is to investigate the effectiveness of using mobile devices to intervene in the self-care ability and quality of life of patients with intestinal stoma.
- Research design and objects A single blind-experimental design is adopted. First, those who meet the acceptance criteria and are willing to participate in the research are selected and assigned to the experimental and control groups by random assignment by the computer random number table. It is estimated that 2 people will be needed Nursing staff were admitted in the rectal anal treatment room. Participants were randomly assigned to receive routine discharge care and mobile device guidance or routine outpatient follow-up. Data were collected before the patient was discharged, 1 month, 2 months and 4 months after discharge . The structured questionnaire is filled in by the patient or the researcher.
- statistical methods Descriptive statistics, including frequency distribution and percentage, average and standard deviation, median and interquartile range, and other data to describe the distribution of data; first use the Kolmogorov-Smirnov test to determine whether the data conform to normality Distribution; univariate analysis adopts independent-sample t test or Mann-Whitney U test to compare the difference between the experimental group and the control group in the continuous variables collected, Chi-square test (chi-square test) or Fisher's exact test (Fisher's exact test) compares the difference between the categorical variables collected in the experimental group and the control group; further, binary logistic regression and stepwise regression are used. Regression screening mode method is used to analyze multiple variables to find out the important explanatory factors related to the involvement of mobile devices in personal attributes, self-care ability and quality of life.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional education service program | Placebo comparator | Other: A new APPIncluding the written and verbal health education on preoperative preparation, stoma surgery and postoperative stoma care. At discharge, ET nurses offered teaching information and support for patients, including selection of pouching appliances, drug instructions, health education At each outpatient follow-up, both stomas and patients needed to be assessed. The condition of stoma and peristomal skin, nature and volume of effluent, date of pouch appliances and stoma complications were recorded by ET nurses. |
| mobile care device | Experimental | Other: A new APPThe participants in the intervention group were given the same routine care as the control group pre- and postoperatively. ET nurses taught patients and their family members how to use the home care mobile app before discharge. The home care mobile app was designed and developed for the discharged stoma patients by the research team and an information technology company in March 2021. Patients could receive stoma care from ET nurses through this mobile app at home, not just going to an outpatient clinic. The Major function modules of this mobile app were as follows: (a) appointment: The app users were able to complete the basic personal and medical information and make an appointment with the ET nurse; (b) photograph diagnosis: The ET nurses could make a diagnosis based on the patients' uploaded stoma photographs; and (c) consultation: Patients were able to contact their ET nurses for help and support. This mobile app was used to supplement the outpatient follow-up. |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- diagnosed with primary colorectal cancer;
- at least 20 years of age;
- able to read and speak Mandarin;
- own a smartphone and willingness to use the mobile app after discharge The exclusion criteria
- 1.having other types of cancer; 2.having visual, hearing and/or cognitive impairments/mental disorders; 3.alcohol or drug abuse; 4.dying or having any surgical complications.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| A new APPA new APP for prevention and treatment of complications of intestinal peristomal skin | Other | conventional education service program, mobile care device |
Primary outcome
Quality of life improvement
Time frame: One and a half years
The Enterostomy- QOL was comprised of 30 questionnaires, it covered seven domains: relations with family and friends, Sleep, activity, sexual activity, social relationship, physiology and psychology. The responses rated on a4-point scale Likert scale (1: extremely, 2: quite a lot, 3: somewhat, 4: not at all). The possible scores range was from 37 to 148. Higher scores indicated that patient had a higher level of quality of life.
3 secondary outcomes
Self-care ability improvement
Time frame: One and a half years
hospital medical record for clinical data
Time frame: One and a half years
Stoma complications
Time frame: One and a half years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2023.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A new APP in people with Quality of Life and Mobile Apps, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 5 inclusion and 0 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 16 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life improvement (time frame: One and a half years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Feb 2023.