NCT02209259

Brief Summary

The investigators plan a prospective randomized study to see whether negative questions affect measures of mood, pain, or disability. A total of 175 patients will participate at Massachusetts General Hospital.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
168

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2014

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

Study Start

First participant enrolled

May 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 29, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 5, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

May 14, 2018

Completed
Last Updated

May 14, 2018

Status Verified

May 1, 2018

Enrollment Period

1.8 years

First QC Date

July 29, 2014

Results QC Date

February 2, 2017

Last Update Submit

May 11, 2018

Conditions

Arm Illness

Outcome Measures

Primary Outcomes (1)

  • Patient Reported Outcomes Measurement Information System (PROMIS) Upper Extremity

    A computerized assessment of upper extremity physical function measured at enrollment. The average T score of the U.S. population is 50, so the T score reported compares the study population to the U.S. population, where a T score greater than 50 is better than the average and a T score less than 50 is worse than the average.

    1day

Secondary Outcomes (2)

  • Pain Intensity

    1 day

  • Patient Reported Outcomes Measurement Information System (PROMIS) Depression

    1 day

Study Arms (3)

Intervention Group 1

EXPERIMENTAL

The first intervention group will be comprised of patients who will complete PROMIS Upper Extremity Function, pain intensity, PROMIS depression, and the Positive affect negative affect scale (PANAS) after completing the standard PCS.

Other: PROMIS Upper Extremity FunctionOther: Pain intensityOther: PROMIS depressionOther: Positive affect negative affect scale (PANAS)Other: standard PCS

Intervention Group 2

EXPERIMENTAL

The second intervention group will be comprised of patients who will complete PROMIS Upper Extremity Function, pain intensity, PROMIS depression, and the Positive affect negative affect scale (PANAS) after completing a positively-adjusted version of the PCS.

Other: PROMIS Upper Extremity FunctionOther: Pain intensityOther: PROMIS depressionOther: Positive affect negative affect scale (PANAS)Other: positively-adjusted version of the PCS

Control

EXPERIMENTAL

The third group (the control arm) will complete PROMIS Upper Extremity Function, pain intensity, PROMIS depression, and the Positive affect negative affect scale (PANAS).

Other: PROMIS Upper Extremity FunctionOther: Pain intensityOther: PROMIS depressionOther: Positive affect negative affect scale (PANAS)

Interventions

PROMIS Upper Extremity FunctionOTHER
ControlIntervention Group 1Intervention Group 2
Pain intensityOTHER
ControlIntervention Group 1Intervention Group 2
PROMIS depressionOTHER
ControlIntervention Group 1Intervention Group 2
Positive affect negative affect scale (PANAS)OTHER
ControlIntervention Group 1Intervention Group 2
standard PCSOTHER
Intervention Group 1
positively-adjusted version of the PCSOTHER
Intervention Group 2

Eligibility Criteria

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

You may qualify if:

  • All new and follow-up patients presenting to the Orthopaedic Hand and Upper Extremity Service
  • English fluency and literacy

You may not qualify if:

  • pregnant women
  • Inability to complete enrollment forms due to any mental status or language problems (e.g. dementia, head injury, overall illness).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (4)

  • Sullivan M J L, Bishop S, Pivik J. The Pain Catastrophizing Scale: Development andvalidation. Psychol Assess 1995, 7: 524-532.

    BACKGROUND

  • Zajonc, R.B. Mere exposure: A gateway to the subliminal. Current Directions in Psychological Science 2001, 10 (6): 224-228.

    BACKGROUND

  • Bossen JK, Hageman MG, King JD, Ring DC. Does rewording MRI reports improve patient understanding and emotional response to a clinical report? Clin Orthop Relat Res. 2013 Nov;471(11):3637-44. doi: 10.1007/s11999-013-3100-x. Epub 2013 Jun 13.

    PMID: 23761176BACKGROUND

  • Claessen FM, Mellema JJ, Stoop N, Lubberts B, Ring D, Poolman RW. Influence of Priming on Patient-Reported Outcome Measures: A Randomized Controlled Trial. Psychosomatics. 2016 Jan-Feb;57(1):47-56. doi: 10.1016/j.psym.2015.09.005. Epub 2015 Oct 1.

    PMID: 26683347DERIVED

Results Point of Contact

Title
Taylor Pong
Organization
Massachusetts General Hospital
tpong1@partners.org

Study Officials

  • David Ring, MD, PhD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 29, 2014

First Posted

August 5, 2014

Study Start

May 1, 2014

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

May 14, 2018

Results First Posted

May 14, 2018

Record last verified: 2018-05

Locations

US(1)