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

NCT02644096 | Completed Phase 1 Results

• 1 other identifier: Rehabilitation after THR
• Study Type: interventional
• Target: 175
• Locations: 0 countries
• Sites: N/A

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

Conditions

Total Hip Replacement

Keywords

Rehabilitation; RCT; User Involvement; Self-Rated Health

Outcome Measures

Primary Outcomes (1)

• 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 health status was assessed by Short-Form 36 (SF-36) which is a self-administered generic questionnaire that has been shown to be reliable and valid for measuring functioning, well-being and general health status. The instrument measures the eight health dimensions listed in figure 3. Reflecting the impact of both dysfunctions and general health perception the questionnaire measures: physical function (PF), role physical (RF), bodily pain (BP), social function (SF) role emotional (RE), general health (GH), vitality (VT) and mental health (MH). The questions related to each dimension are scored on a scale from 0 (worst score) to 100 (best score). All patients who had been consecutively admitted for THR were mailed an introduction letter together with a questionnaire containing a number and a prepaid return envelope. In the questionnaire they were asked to give demographic data and assess their health status

  Four weeks preoperatively and nine moths after discharge.

Study Arms (2)

conventional treatment

NO INTERVENTION

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

Intervention

OTHER

counselling and support after discharge from hospital

Other: counselling and support after discharge from hospital

Interventions

counselling and support after discharge from hospital 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

Intervention

Eligibility Criteria

• Age: 65 Years - 97 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Patients enrolled to THR
• Being able to read and understand Danish

You may not qualify if:

• Patients not being able to participate or refused
• Any condition that makes the subject unable to participate in the opinion of the investigator.

Sponsors & Collaborators

• University of Aarhus: lead
• Sygekassernes Helsefond: collaborator
• TrygFonden, Denmark: collaborator
• Region Zealand: collaborator

MeSH Terms

Interventions

Counseling

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Chief researcher Britta Hørdam
• Organization: University of Copenhagen

britta@hordam.dk

+ 45 22214383

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior researcher

Study Record Dates

• First Submitted: August 3, 2015
• First Posted: December 31, 2015
• Study Start: September 1, 2004
• Primary Completion: September 1, 2007
• Study Completion: December 1, 2013
• Last Updated: August 12, 2016
• Results First Posted: June 20, 2016

Record last verified: 2016-07