- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT02815163
The Effects of Using the Empowerment Model Intervention in Primary Total Hip Replacement Surgery Elders
The Effects of Using the Empowerment Model Intervention in Primary Total Hip
Přehled studie
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- had 1st THRS
- ability to speak and read Chinese
- willingness to participate in this study
Exclusion Criteria:
- cognitive impairment or been diagnosed with a psychiatric illness
- participation in another study
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
---|---|
Žádný zásah: comparison group
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.
|
|
Experimentální: Empowerment education group
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.
|
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Total Hip Replacement Self-efficacy Scale
Časové okno: 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.
|
5min
|
Self-care competence Scale
Časové okno: 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.
|
5min
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
ADL
Časové okno: 3min
|
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.
|
3min
|
Tinetti mobility
Časové okno: 3min
|
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.
|
3min
|
GDS-15
Časové okno: 3min
|
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.
|
3min
|
SF-36
Časové okno: 3min
|
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.
|
3min
|
Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další identifikační čísla studie
- 97-2081B
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
Klinické studie na Empowerment education
-
Psychiatric Research Unit, Region Zealand, DenmarkStaženoPsychiatrická hospitalizace
-
International Rescue CommitteeGeorge Washington University; World Health OrganizationZatím nenabírámeIntimní partnerské násilí
-
US Department of Veterans AffairsIndiana University School of MedicineDokončeno
-
New York UniversityDokončeno
-
Northwestern UniversityNational Institute on Drug Abuse (NIDA); Brown University; Rhode Island HospitalNáborPuberťák | Užívání konopíSpojené státy
-
Aveiro UniversityNeznámýBolest krkuPortugalsko
-
Selcuk UniversityDokončenoPraxe založená na důkazechKrocan
-
University of South FloridaNational Cancer Institute (NCI)StaženoDětská rakovinaSpojené státy
-
Dartmouth-Hitchcock Medical CenterNational Institute of Mental Health (NIMH)DokončenoDuševní poruchy | Deprese | Posttraumatická stresová poruchaSpojené státy
-
Scripps Whittier Diabetes InstituteNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); San... a další spolupracovníciDokončenoCukrovka typu 2Spojené státy