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

NCT ID: NCT01775332

Last Updated: 2015-07-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2015-12-31

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.

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.

Conditions

Pituitary Neoplasms; Prolactinoma; ACTH-Secreting Pituitary Adenoma; Gigantism; Growth Hormone-Secreting Pituitary Adenoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Educational Intervention

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

Group Type: EXPERIMENTAL

Educational Intervention

Intervention Type: OTHER

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

No Intervention/Use of Own Resources

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Educational Intervention

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

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Unity Health Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Cusimano, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Unity Health Toronto

Locations

St. Michael's Hospital

Toronto, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Stanley Zhang, B.M.

Role: CONTACT

injuryprevention@smh.ca

416-864-5312

Facility Contacts

Stanley Zhang, B.M.

Role: primary

injuryprevention@smh.ca

416-864-5312

References

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.

Reference Type: BACKGROUND

PMID: 17931131 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16583727 (View on PubMed)

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

Reference Type: BACKGROUND

Other Identifiers

SMHAIF - 058

Identifier Type: -

Identifier Source: org_study_id