EmpowermentNCT02815163
The Effects of Using the Empowerment Model Intervention in Primary Total Hip Replacement Surgery Elders
A study testing Empowerment education in people with Empowerment, run by Tzu-Ting Huang.
Trial summary
Degenerative arthritis is a common and serious chronic illness that impacts the quality of life of older adults. Knowledge about the effects of empowerment education program in older adults with total hip replacement surgery are limited. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Empowerment
- What is being tested?
- Empowerment education
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- No sites listed yet
- Study dates
- Sep 2013to May 2014
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- had 1st THRS
- ability to speak and read Chinese
- willingness to participate in this study
Who cannot join
- cognitive impairment or been diagnosed with a psychiatric illness
- participation in another study
About this study
Official title: The Effects of Using the Empowerment Model Intervention in Primary Total Hip
Degenerative arthritis is a common and serious chronic illness that impacts the quality of life of older adults. Knowledge about the effects of empowerment education program in older adults with total hip replacement surgery are limited. As far as the investigators know, this is the first study done using empowerment education intervention to promote total hip replacement patients' self-care. This partnership is achieved through active participation to learn as well as sharing their knowledge and experiences with clinicians and patients. Furthermore, patients had developed some degree of self-efficacy and improve their depressive mood from the disease related knowledge acquired.
Read the detailed description
Aims. To exam the effectiveness of the empowerment education program on primary (self-care self-efficacy and competence) and secondary outcomes (Activities of Daily Life, mobility, depressive mood, and quality of life) for older adults with total hip replacement surgery.
Background. Degenerative arthritis is a common and serious chronic illness that impacts the quality of life of older adults. As joints degenerate continuously and the hip has been damaged by arthritis, Activities of Daily Life will be difficult to perform due to severe hip pain and joint stiffness. Therefore, hip replacement surgery should be considered, and effective nursing care should be provided to improve the recovery of older adults.
Design. A prospective randomized control trial. Methods. A trial was conducted from September of 2013 to May of 2014 in two hospitals in northern Taiwan. 108 participants were randomly assigned to either the empowerment education group or the comparison group. The outcomes were collected at the day of discharge (T2), one month after (T3), and 3 months (T4) after the discharge.
- Conditions
- Empowerment
- Being tested
- Empowerment education
- Medical subject headings
- Empowerment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empowerment educationOther
- admission (1 hour) ▪partnership
- 2 ds after THR (30-45min)
- listening
- dialogue
- reflection
- action
- feedback
- 2 WKs after THR (30 min)
- listening
- dialogue
- reflection
- action
- feedback
- 6 WKs after THR (30 min)
- listening
- dialogue
- reflection
- action
- feedback
- 10 WKs after THR (30 min)
- listening
- dialogue
- reflection
- action
- feedback
| Study group | Role | What they receive |
|---|---|---|
| comparison group | No intervention | The CG received no extra care; they could receive the usual routine care for THR in the unit as they had before participation in the study. The routine care included oral instruction by nurses follow by the handout. Also, a brochure was provided of the structure of hip, the risk factors of THR, care before and after THR, complications, care of discharge, and demonstration of rehabilitation with pictures) of THR designed by researchers in this study. Five orthopedics health care experts independently reviewed and rated each item in the brochure on a five-point Likert-type scale in terms of relevance, representativeness, specificity, and clarity. |
| Empowerment education group | Experimental | The 5 times total, 12-week EE intervention was aimed to empower older patients with THR to develop their own self-management program to meet their needs. This empowerment education intervention based on 6 empowerment components: "Partnership, listening, dialogue, reflection, action, feedback" and 5-step empowerment strategies: motivating patients self-awareness, assessing the causes of the problem, goal setting, individual self-care plan development, and checking whether goals or plans have been achieved who modified from Freire's 3-stage methodology. The difference between this program and the other health educations for patients with THR are that this program encourages them to explore their needs and worries, their own ability and power to meet their needs, and their capacity to seek and use their social support and resources etc. Receives: Other: Empowerment education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Hip Replacement Self-efficacy Scale
A five-item evaluation list measured self-efficacy (environment, self-monitoring, regular check-up, medicine, exercise), all components were rated on a 5-point Likert-type scale (4= fully confident to 0= no confidence at all) with higher scores signifying greater self-efficacy.
Measured: 5min
Self-care competence Scale
The knowledge and behaviors subscales measured this variable, which includes knowledge and behavior related to THR self-care. The knowledge subscale contains 15 yes/no questions (6 for posture/ environment, 6 for wound/pain, and 3 for exercise), each with only one correct response. In order to prevent participants that guessed answers from confounding the data, the choice 'I do not know' was also provided. The scores range from 0 to 15, with higher scores indicating greater knowledge.
Measured: 5min
Secondary outcomes (4)
ADL
ADL was assessed using the Barthel scale, which was introduced in 1965 and yielded a score of 0-100, the measure 10 variables. These variables included fecal incontinence, urinary incontinence, and assistance with grooming, feeding, transfers, walking, dressing, climbing stairs, and bathing.
Measured: 3min
Tinetti mobility
The Tinetti Mobility Scale (Tinetti et al. 1986) assessed mobility (gait and balance). This scale is simple: no required equipment attached and is quick and convenient to use. Each participant took around 5 minutes to perform the series of activities to assess mobility. The better a participant's performance, the higher the score.
Measured: 3min
GDS-15
consisting of 15 questions, was the primary outcome evaluator (Sheikh and Yesavage, 1986). Scores of 0-4 are considered to be normal; 5-8 indicates mild depression; 9-11 indicates moderate depression; and 12-15 indicates severe depression.
Measured: 3min
SF-36
The SF-36 questionnaire assesses health-related functions for eight distinct domains, which can be divided into physical component and mental component scales. This 36-item questionnaire was used to measure quality of life.
Measured: 3min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2016 (estimated)
- Study startSep 2013
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EmpowermentStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tzu-Ting Huang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tzu-Ting Huang, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02815163
- Sponsor's protocol ID
- 97-2081B
- Status last verified
- May 2018
- First submitted
- 21 Jun 2016
- Last updated
- 23 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Using the Empowerment Model Intervention in Primary Total Hip
- ClinicalTrials.gov ID
- NCT02815163
- Acronym / sponsor ID
- 97-2081B
- Conditions
- Empowerment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Tzu-Ting HuangUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 28 Jun 2016 (estimated)
- 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.
Degenerative arthritis is a common and serious chronic illness that impacts the quality of life of older adults. Knowledge about the effects of empowerment education program in older adults with total hip replacement surgery are limited. As far as the investigators know, this is the first study done using empowerment education intervention to promote total hip replacement patients' self-care. This partnership is achieved through active participation to learn as well as sharing their knowledge and experiences with clinicians and patients. Furthermore, patients had developed some degree of self-efficacy and improve their depressive mood from the disease related knowledge acquired.
Detailed description
Aims. To exam the effectiveness of the empowerment education program on primary (self-care self-efficacy and competence) and secondary outcomes (Activities of Daily Life, mobility, depressive mood, and quality of life) for older adults with total hip replacement surgery.
Background. Degenerative arthritis is a common and serious chronic illness that impacts the quality of life of older adults. As joints degenerate continuously and the hip has been damaged by arthritis, Activities of Daily Life will be difficult to perform due to severe hip pain and joint stiffness. Therefore, hip replacement surgery should be considered, and effective nursing care should be provided to improve the recovery of older adults.
Design. A prospective randomized control trial. Methods. A trial was conducted from September of 2013 to May of 2014 in two hospitals in northern Taiwan. 108 participants were randomly assigned to either the empowerment education group or the comparison group. The outcomes were collected at the day of discharge (T2), one month after (T3), and 3 months (T4) after the discharge.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| comparison group | No intervention | –The CG received no extra care; they could receive the usual routine care for THR in the unit as they had before participation in the study. The routine care included oral instruction by nurses follow by the handout. Also, a brochure was provided of the structure of hip, the risk factors of THR, care before and after THR, complications, care of discharge, and demonstration of rehabilitation with pictures) of THR designed by researchers in this study. Five orthopedics health care experts independently reviewed and rated each item in the brochure on a five-point Likert-type scale in terms of relevance, representativeness, specificity, and clarity. |
| Empowerment education group | Experimental | Other: Empowerment educationThe 5 times total, 12-week EE intervention was aimed to empower older patients with THR to develop their own self-management program to meet their needs. This empowerment education intervention based on 6 empowerment components: "Partnership, listening, dialogue, reflection, action, feedback" and 5-step empowerment strategies: motivating patients self-awareness, assessing the causes of the problem, goal setting, individual self-care plan development, and checking whether goals or plans have been achieved who modified from Freire's 3-stage methodology. The difference between this program and the other health educations for patients with THR are that this program encourages them to explore their needs and worries, their own ability and power to meet their needs, and their capacity to seek and use their social support and resources etc. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- had 1st THRS
- ability to speak and read Chinese
- willingness to participate in this study
Key exclusion criteria (2 listed)
- cognitive impairment or been diagnosed with a psychiatric illness
- participation in another study
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 |
|---|---|---|
| Empowerment education1. admission (1 hour) ▪partnership 2. 2 ds after THR (30-45min) * listening * dialogue * reflection * action * feedback 3. 2 WKs after THR (30 min) * listening * dialogue * reflection * action * feedback 4. 6 WKs after THR (30 min) * listening * dialogue * reflection * action * feedback 5. 10 WKs after THR (30 min) * listening * dialogue * reflection * action * feedback | Other | Empowerment education group |
Primary outcome
Total Hip Replacement Self-efficacy Scale
Time frame: 5min
A five-item evaluation list measured self-efficacy (environment, self-monitoring, regular check-up, medicine, exercise), all components were rated on a 5-point Likert-type scale (4= fully confident to 0= no confidence at all) with higher scores signifying greater self-efficacy.
Self-care competence Scale
Time frame: 5min
The knowledge and behaviors subscales measured this variable, which includes knowledge and behavior related to THR self-care. The knowledge subscale contains 15 yes/no questions (6 for posture/ environment, 6 for wound/pain, and 3 for exercise), each with only one correct response. In order to prevent participants that guessed answers from confounding the data, the choice 'I do not know' was also provided. The scores range from 0 to 15, with higher scores indicating greater knowledge.
4 secondary outcomes
ADL
Time frame: 3min
Tinetti mobility
Time frame: 3min
GDS-15
Time frame: 3min
SF-36
Time frame: 3min
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2018.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Empowerment education in people with Empowerment, run by Tzu-Ting Huang.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 23 May 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Hip Replacement Self-efficacy Scale (time frame: 5min). The study lists 2 primary outcomes in all. 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 23 May 2018.