NCT01775332

Brief Summary

The purpose of this research study is to determine the utility of educational materials designed to inform patients of their pituitary condition, in an effort to assist the patients, families, and staff deal with pituitary tumours and related conditions in the best way possible. We have developed a website, informational videos, and a brochure for pituitary tumour patients and their families. The primary outcome measures will be 1) the level of knowledge that patients have of their condition before and after reviewing the materials provided; and 2) ease of use and user satisfaction of the materials. We hypothesize that our informative multimedia educational package will not only improve the health literacy and self-efficacy of patients and their families, but will also improve quality of care.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

January 22, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 24, 2013

Completed
1 year until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

July 31, 2015

Status Verified

July 1, 2015

Enrollment Period

1.8 years

First QC Date

January 22, 2013

Last Update Submit

July 30, 2015

Conditions

Pituitary NeoplasmsProlactinomaACTH-Secreting Pituitary AdenomaGigantismGrowth Hormone-Secreting Pituitary Adenoma

Outcome Measures

Primary Outcomes (1)

  • The level of knowledge that patients have of their condition before and after reviewing the materials provided, and ease of use of educational materials and user satisfaction

    1-2 yrs

Study Arms (2)

Educational Intervention

EXPERIMENTAL

Educational Intervention - Access to educational materials provided (i.e. website, videos, brochure)

Other: Educational Intervention

No Intervention/Use of Own Resources

NO INTERVENTION

No educational materials are provided to participants, but they can use their own resources

Interventions

Educational InterventionOTHER

A brochure and access to a website including videos that contain detailed information about pituitary disorders will serve as the educational intervention.

Educational Intervention

Eligibility Criteria

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

You may qualify if:

  • age equal to or greater than 18 years;
  • capable of providing consent to participate on their own behalf;
  • diagnosed with a pituitary disorder OR have a history of pituitary disorder AND a current/former patient at St. Michael's Hospital, OR be a caretaker of someone with a pituitary disorder;
  • adequate written/verbal English skills.

You may not qualify if:

  • Younger than 18 years;
  • Unable to provide consent;
  • Unable to communicate in written/verbal English, as all of the surveys and interviews are administered in English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Michael's Hospital

Toronto, Ontario, M5B1T8, Canada

RECRUITING

Related Publications (3)

  • Andrulis DP, Brach C. Integrating literacy, culture, and language to improve health care quality for diverse populations. Am J Health Behav. 2007 Sep-Oct;31 Suppl 1(Suppl 1):S122-33. doi: 10.5555/ajhb.2007.31.supp.S122.

    PMID: 17931131BACKGROUND

  • Kan P, Cusimano M. Validation of a quality-of-life questionnaire for patients with pituitary adenoma. Can J Neurol Sci. 2006 Feb;33(1):80-5. doi: 10.1017/s0317167100004741.

    PMID: 16583727BACKGROUND

  • Goguen, J. (2007). Perioperative management of the pituitary patients. Endocrinology Rounds, 7(9): 1-6. Retrieved February 2, 2011 from http://www.endocrinologyrounds.ca

    BACKGROUND

MeSH Terms

Conditions

Pituitary NeoplasmsProlactinomaACTH-Secreting Pituitary AdenomaGigantismGrowth Hormone-Secreting Pituitary Adenoma

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHypothalamic NeoplasmsSupratentorial NeoplasmsBrain NeoplasmsCentral Nervous System NeoplasmsNervous System NeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesHypothalamic DiseasesPituitary DiseasesEndocrine System DiseasesAdenomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeBone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesBone Diseases, EndocrineHyperpituitarism

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health Services

Study Officials

  • Michael Cusimano, MD, PhD

    Unity Health Toronto

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Stanley Zhang, B.M.

CONTACT

416-864-5312injuryprevention@smh.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2013

First Posted

January 24, 2013

Study Start

February 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

July 31, 2015

Record last verified: 2015-07

Locations

CA(1)