NCT04452903

Brief Summary

The aim of this study is to test the effectiveness of a single training session in communication skills at improving patients' perceptions of physiotherapy consultations.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
558

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 24, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 1, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

July 1, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 29, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2020

Completed
Last Updated

January 13, 2021

Status Verified

June 1, 2020

Enrollment Period

4 months

First QC Date

June 24, 2020

Last Update Submit

January 12, 2021

Conditions

Communication

Keywords

communication skillsConsultation reassurance questionnaire

Outcome Measures

Primary Outcomes (1)

  • Consultation reassurance questionnaire (0-72). Change is being assess before and after the intervention.

    A questionnaire that measures patients' perceptions of consultation- higher values represent a better communication skills

    measure assessing change between two time points: base line and at two month.

Secondary Outcomes (3)

  • The numeric pain rating scale (0-10)

    2 month

  • Disability (0-10)

    2 month

  • Satisfaction (0-10)

    2 month

Study Arms (2)

Reassurance intervention

EXPERIMENTAL

The physiotherapist in the intervention group (n=15) will participate in a 3-hour communication skill workshop, followed by a month-long period to assimilate and implement the new set of skills, with supervision available by phone from the trainers.

Behavioral: communication skills

Control

NO INTERVENTION

The physiotherapist in the control group (n=15) receives no training.

Interventions

communication skillsBEHAVIORAL

3-hour communication skill workshop, followed by a month-long period to assimilate and implement the new set of skills, with supervision available by phone from the trainers.

Reassurance intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Physiotherapists:
  • Working for Clalit Health Services. Dan-Petach Tikva region
  • Willing to participate in a 3-hour communication skills workshop
  • Patients:
  • over the age of 18
  • literate in Hebrew
  • Willing to participate in the study

You may not qualify if:

  • Unwilling to participate in the trial
  • Illiterate in Hebrew

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Distric DAN - PETACH TIKVA

Petah Tikva, Israel

Location

Related Publications (3)

  • Holt N, Pincus T. Developing and testing a measure of consultation-based reassurance for people with low back pain in primary care: a cross-sectional study. BMC Musculoskelet Disord. 2016 Jul 12;17:277. doi: 10.1186/s12891-016-1144-2.

    PMID: 27405870RESULT

  • Pincus T, Holt N, Vogel S, Underwood M, Savage R, Walsh DA, Taylor SJC. Cognitive and affective reassurance and patient outcomes in primary care: a systematic review. Pain. 2013 Nov;154(11):2407-2416. doi: 10.1016/j.pain.2013.07.019. Epub 2013 Jul 18.

    PMID: 23872104RESULT

  • Holt N, Mansell G, Hill JC, Pincus T. Testing a Model of Consultation-based Reassurance and Back Pain Outcomes With Psychological Risk as Moderator: A Prospective Cohort Study. Clin J Pain. 2018 Apr;34(4):339-348. doi: 10.1097/AJP.0000000000000541.

    PMID: 29509169RESULT

MeSH Terms

Conditions

Communication

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Noa Ben Ami, PhD

    Ariel University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
The participant (patients of the physiotherapists) are unaware of the intervention. The outcome assessor will not know who was in the intervention group and who was in the control
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: A randomized controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2020

First Posted

July 1, 2020

Study Start

July 1, 2020

Primary Completion

October 29, 2020

Study Completion

December 20, 2020

Last Updated

January 13, 2021

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)