Interdisciplinary Pituitary Disorders Centre of Excellence: Assessment of Patient Education Tools

Prolactinoma Clinical Trial

Official title:

Interdisciplinary Pituitary Disorders Centre of Excellence: Assessment of Patient Education Tools

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01775332
• Other study ID #: SMHAIF - 058
• Status: Recruiting
• Phase: N/A
• First received: January 22, 2013
• Last updated: July 30, 2015
• Start date: February 2014
• Est. completion date: December 2015

Study information

• Verified date: July 2015
• Source: St. Michael's Hospital, Toronto
• Contact: Stanley Zhang, B.M.
• Phone: 416-864-5312
• Email: injuryprevention[@]smh.ca
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Description:

This study involves a formative evaluation of the health literacy resources that we have already developed. We see approximately 60 new patients a year with pituitary disorders, plus the follow-up patients: all of these patients will be offered the opportunity to participate in the study. These materials include a website (containing videos, illustrations and written materials) and plain language educational brochures. The educational materials include information that patients will need throughout their experience with a pituitary tumour, ranging from the signs and symptoms of tumours, to long-term post-operative lifestyle changes. This evaluation will be a mixed-methods evaluation.

Part A (Think aloud) will use "think-aloud" processes to evaluate the usefulness and ease of use of a website that we have developed with patients and their families.

Part B (Resource assessment) will involve the use of questionnaires followed by semi-structured interviews with patients and families before and after using the resources.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• ACTH-Secreting Pituitary Adenoma
• Adenoma
• Gigantism
• Growth Hormone-Secreting Pituitary Adenoma
• Pituitary Diseases
• Pituitary Neoplasms
• Prolactinoma

Intervention

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

Locations

Country	Name	City	State
Canada	St. Michael's Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
St. Michael's Hospital, Toronto

Country where clinical trial is conducted

Canada, 

References & 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:S122-33. — View Citation

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

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No