Rehabilitation of Patients After THR - Based on Patients´Selfrated Health

Rehabilitation Clinical Trial

— Rehab-THR  

Official title:

Rehabilitation of Patients Aged 65 and Over After Total Hip Replacement - Based on Patients´Health Status

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02644096
• Other study ID #: Rehabilitation after THR
• Status: Completed
• Phase: Phase 1
• First received: August 3, 2015
• Last updated: December 28, 2015
• Start date: September 2004
• Est. completion date: December 2013

Study information

• Verified date: December 2015
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial Summary

Objective: The investigators hypothesized that all areas of health status after total hip replacement could be improved in patients aged over 65 years and over by using telephone support and counselling 2 and 10 weeks after surgery compared with a control group receiving conventional care and treatment.

Design: A randomised clinical trial focusing on patients' health status by using SF-36 at 4 weeks pre- and 3 and 9 months postoperatively was carried out. Sample: 180 patients aged 65 and over were randomised 4 weeks preoperatively to either control or intervention groups. Measurements: Both groups received conventional surgical treatment, but the intervention group was interviewed by telephone 2 and 10 weeks after surgery. Patients were given counselling within eight main dimensions with reference to their postoperative situation.

Key-words: THR - elderly patients - health status - postoperative support - counselling

Description:

Primary outcome: the physical dimensions in health status. The intervention could lead to an improvement of 50% in the physical health score on the SF-36 questionnaire.

Theoretical frame of reference: the nursing intervention in this study was based on the Murray and Maslow's theories of motivation combined with Piaget's theory of development in which the main goal is to promote and maintain patients' active involvement in their own care.

Intervention: All patients received the standard postoperative procedure in the hospital, which means discharge after 5-7 days and a clinical control in the outpatient department after 3 months. But the intervention group also received telephone support and counselling 2 and 10 weeks after surgery. The intervention was performed by the same nurse using a structured interview guide to identify the patients' perceptions of their current situations and need for further support and counselling of importance to their health status. Together the patients and the nurse assessed the patients' situation and areas of improvements. The assessment focused on eight main dimensions referring to the patients' situation after Total Hip Replacement (THR). (1) Wellbeing. (2) Expectations as to PF after surgery. (3) Expectations as to PF compared with those before surgery. (4) Symptoms (pain, leg-oedema, vertigo, sleep disturbance, nausea and other concerns) and (5) Problems with eating and appetite. (6) Fluid intake. (7) Ability to follow prescribed activity and exercise. (8) Need of support from family. For each of the problems identified,individual solutions were suggested and practical counselling was given by the investigator.

Statistical analysis: Data were processed by using the statistical program Statistical Package for Social Sciences (SPSS) version 13.0 (Boston, MA, USA). Ratio-scaled data from both groups (intervention and control) were compared by using parametric methods if data were normally distributed, but if not, nonparametric methods were used. Nominal scaled data were compared by using the chi-square test or using 95% CI around the association measure.

Categorical variables were compared using Pearson's chi-square test if appropriate. For continuous data, changes within the groups were analysed by using a paired t-test. Groups were compared using an unpaired t-test (for normally distributed data). p < 0.05 were considered statistically significant.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 175
• Est. completion date: December 2013
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years to 97 Years

Eligibility

Inclusion Criteria:

• Patients enrolled to THR

• Being able to read and understand Danish

Exclusion Criteria:

• Patients not being able to participate or refused

• Any condition that makes the subject unable to participate in the opinion of the investigator.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Randomized Controlled Trial
• Rehabilitation
• Self Reported Health
• Total Hip Replacement

Intervention

Other:
• counselling and support after discharge from hospital
patients were contacted by telephone 2 times after discharge from surgery by a specialist nurse, who followed an interview guide due to nursing-rehabilitation after THR

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
University of Aarhus	Region Zealand, Sygekassernes Helsefond, TrygFonden, Denmark

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in physical dimensions in health status of elderly patients from 4 weeks pre operatively to 9 months post operatively after THR. Health status is measured by the questionnaire short-form 36 (SF-36).	The effect of the intervention will be measured on patients' health status. Data on patients' health status will be collected by a mailed questionnaire.; SF-36 is a self-administered generic questionnaire measuring physical and emotional functioning and the perception of general health.The instrument measures two dimensions of health on eight subscales, reflecting the impact of both dysfunctions and general health perceptions. Dysfunctions are measured with the following subscales: physical function, role physical, bodily pain, social function, role emotional. Health perception is measured with three subscales: general health, vitality and mental health.	Four weeks preoperatively, three and nine moths after discharge.	Yes