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

NCT ID: NCT02644096

Last Updated: 2016-08-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 175 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-09-30
• Study Completion Date: 2013-12-31

Brief 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

Detailed 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.

Conditions

Total Hip Replacement

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

conventional treatment

After surgery, patients with total hip replacement are only seen once 3 months after surgery, and they have no further contact with the hospital.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention

counselling and support after discharge from hospital

Group Type: OTHER

counselling and support after discharge from hospital

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 97 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Aarhus

OTHER

Sponsor Role: lead

Sygekassernes Helsefond

OTHER

Sponsor Role: collaborator

TrygFonden, Denmark

INDUSTRY

Sponsor Role: collaborator

Region Zealand

OTHER

Sponsor Role: collaborator

Responsible Party

Britta Hørdam

Senior researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

Rehabilitation after THR

Identifier Type: -

Identifier Source: org_study_id