Interdisciplinary Pituitary Disorders Centre of Excellence: Assessment of Patient Education Tools
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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 Endpoint Classification: Efficacy Study 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 |
- 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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | February 2013 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2014 (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 |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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| Contact: Emily Lam, MSc | 416-864-5312 | lamemi@smh.ca |
| Contact: Stanley Zhang, B.M. | 416-864-5312 | ZhangSh@smh.ca |
| Canada, Ontario | |
| St. Michael's Hospital | Not yet recruiting |
| Toronto, Ontario, Canada, M5B1T8 | |
| Contact: Emily Lam, MSc 416-864-5312 lamemi@smh.ca | |
| Principal Investigator: Michael Cusimano, MD, PhD | |
| Principal Investigator: | Michael Cusimano, MD, PhD | St. Michael's Hospital, Toronto |
More Information
Publications:
| Responsible Party: | Michael Cusimano, MD, PhD, 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: | January 22, 2013 |
| Health Authority: | Canada: Ethics Review Committee |
Additional relevant MeSH terms:
|
Neoplasms Pituitary Neoplasms Pituitary Diseases Growth Hormone-Secreting Pituitary Adenoma ACTH-Secreting Pituitary Adenoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Endocrine Gland Neoplasms Neoplasms by Site Hypothalamic Neoplasms Supratentorial Neoplasms Brain Neoplasms Central Nervous System Neoplasms Nervous System Neoplasms |
Adenoma Gigantism Prolactinoma Bone Diseases, Developmental Bone Diseases Musculoskeletal Diseases Bone Diseases, Endocrine Hyperpituitarism Endocrine System Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Hypothalamic Diseases |
ClinicalTrials.gov processed this record on May 16, 2013