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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2015 by St. Michael's Hospital, Toronto.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01775332
First Posted: January 24, 2013
Last Update Posted: July 31, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto
  Purpose
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.

Condition Intervention
Pituitary Neoplasms Prolactinoma ACTH-Secreting Pituitary Adenoma Gigantism Growth Hormone-Secreting Pituitary Adenoma Other: Educational Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Interdisciplinary Pituitary Disorders Centre of Excellence: Assessment of Patient Education Tools

Resource links provided by NLM:


Further study details as provided by St. Michael's Hospital, Toronto:

Primary Outcome Measures:
  • 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 [ Time Frame: 1-2 yrs ]

Estimated Enrollment: 60
Study Start Date: February 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Educational Intervention
Educational Intervention - Access to educational materials provided (i.e. website, videos, brochure)
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.
No Intervention: No Intervention/Use of Own Resources
No educational materials are provided to participants, but they can use their own resources

Detailed 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01775332


Contacts
Contact: Stanley Zhang, B.M. 416-864-5312 injuryprevention@smh.ca

Locations
Canada, Ontario
St. Michael's Hospital Recruiting
Toronto, Ontario, Canada, M5B1T8
Contact: Stanley Zhang, B.M.    416-864-5312    injuryprevention@smh.ca   
Principal Investigator: Michael Cusimano, MD, PhD         
Sponsors and Collaborators
St. Michael's Hospital, Toronto
Investigators
Principal Investigator: Michael Cusimano, MD, PhD St. Michael's Hospital, Toronto
  More Information

Publications:
Responsible Party: St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT01775332     History of Changes
Other Study ID Numbers: SMHAIF - 058
First Submitted: January 22, 2013
First Posted: January 24, 2013
Last Update Posted: July 31, 2015
Last Verified: July 2015

Additional relevant MeSH terms:
Pituitary Neoplasms
Adenoma
Pituitary Diseases
Prolactinoma
Gigantism
Growth Hormone-Secreting Pituitary Adenoma
ACTH-Secreting Pituitary Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Hypothalamic Neoplasms
Supratentorial Neoplasms
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Hyperpituitarism