- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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
Studieoversikt
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Ingen inngripen: 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.
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Eksperimentell: 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.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Total Hip Replacement Self-efficacy Scale
Tidsramme: 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.
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5min
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Self-care competence Scale
Tidsramme: 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.
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5min
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
ADL
Tidsramme: 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.
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3min
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Tinetti mobility
Tidsramme: 3min
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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.
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3min
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GDS-15
Tidsramme: 3min
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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.
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3min
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SF-36
Tidsramme: 3min
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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.
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3min
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Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 97-2081B
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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