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Trial record 2 of 4 for:
"Gigantism"
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
Recruitment status was: Recruiting
Sponsor:
St. Michael's Hospital, Toronto
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier:
NCT01775332
First received: January 22, 2013
Last updated: July 30, 2015
Last verified: July 2015
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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 Blind (Outcomes Assessor) Primary Purpose: Supportive Care |
| Official Title: | Interdisciplinary Pituitary Disorders Centre of Excellence: Assessment of Patient Education Tools |
Resource links provided by NLM:
Genetics Home Reference related topics:
familial isolated pituitary adenoma
MedlinePlus related topics:
Pituitary Disorders
Genetic and Rare Diseases Information Center resources:
ACTH-secreting Pituitary Adenoma
Prolactinoma
Gigantism
U.S. FDA Resources
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| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01775332
Please refer to this study by its ClinicalTrials.gov identifier: 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:
Goguen, J. (2007). Perioperative management of the pituitary patients. Endocrinology Rounds, 7(9): 1-6. Retrieved February 2, 2011 from http://www.endocrinologyrounds.ca
| Responsible Party: | St. Michael's Hospital, Toronto |
| ClinicalTrials.gov Identifier: | NCT01775332 History of Changes |
| Other Study ID Numbers: |
SMHAIF - 058 |
| Study First Received: | January 22, 2013 |
| Last Updated: | July 30, 2015 |
Additional relevant MeSH terms:
|
Gigantism Adenoma Pituitary Diseases Pituitary Neoplasms Prolactinoma 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 |
ClinicalTrials.gov processed this record on July 13, 2017