iPad Use in Reducing Anxiety and Depression in Patients Undergoing Bone Marrow Transplant

Depression Clinical Trial

— BUCKiPAD  

Official title:

Project BUCKiPAD: The Evaluation of an iPAD Distribution Program on Anxiety and Depression in Bone and Marrow Transplant Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02378012
• Other study ID #: OSU-12207
• Secondary ID: NCI-2014-00935
• Status: Terminated
• Phase: N/A
• Start date: March 19, 2014
• Est. completion date: September 6, 2014

Study information

• Verified date: June 2020
• Source: Ohio State University Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This randomized clinical trial studies iPad use in reducing anxiety and depression in patients undergoing bone marrow transplant. A tablet device like the iPad can provide access to music, television, movies, books, and the Internet. It also contains a video conferencing system that can allow patients to communicate with family members and other members of their social support team. With these capabilities, an iPad distribution program may help lessen patient anxiety and depression during a hospital stay. Monitoring iPad use by patients may help doctors better understand how patients use their computers and tablets while in the hospital so that the software and applications of the iPad can be made more useful.

Description:

PRIMARY OBJECTIVES:

I. To evaluate the effect access to an iPad has on anxiety as measured by the Hospital Anxiety and Depression Scale.

SECONDARY OBJECTIVES:

I. Determine how computers and tablets are used by patients who have access to such devices.

OUTLINE: Participants are assigned to Group A or randomized to 1 of 2 groups (Groups B or C).

GROUP A (participants provide their own computer or tablet device): A member of the research personnel helps the participants install Netflix, Spotify, and Skype applications on their computers if they wish to do so. Participants will be given subscriptions to each application and usernames for access on days -5 to 10.

GROUP B (Apple iPad): Participants receive an iPad for days -5 to 10. Participants also receive the BuckiPad manual for instructions on how to use the iPad and Netflix, Skype, and Spotify applications. Participants are also directed to the official Apple's iPad user's manual on their device and have questions answered by research personnel on day -5.

GROUP C: Participants do not receive an iPad for days -5 to 10.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: September 6, 2014
• Est. primary completion date: September 6, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients undergoing treatment in the bone marrow transplant (BMT) unit on the 3rd floor of the James Cancer Hospital and Solove Research Institute

• Patients receiving reduced intensity chemotherapy for an allogeneic stem cell transplant

Exclusion Criteria:

• Patients who lack the visual or motor skills necessary to use a tablet device like the Apple iPad

• Criteria for visual proficiency will be determined by asking the patient: do you have trouble reading a newspaper even with your glasses or contacts (if you wear them); if "yes", they will be excluded

• Criteria for motor skill proficiency will be determined by asking the patient: do you have any trouble using a television remote control; if "yes", they will be excluded

• Patients who do not speak English

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Depression
• Depressive Disorder
• Malignant Neoplasm
• Neoplasms

Intervention

Other:
• Computer-Assisted Intervention
Receive access to Netflix, Spotify, and Skype applications
• Computer-Assisted Intervention
Receive iPad and instruction manuals.
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Hospital Anxiety and Depression Scale (HADS)-Anxiety score	Will be analyzed using an analysis of covariance (ANCOVA) model containing fixed effects of treatment condition (iPAD vs. no iPAD), baseline HADS-Anxiety score, and a random, normally distributed error term. The data will be log-transformed prior to analysis, so all resulting inferences will be based on the geometric mean instead of the arithmetic mean.	Baseline to day 10
Secondary	Change in HADS depression score	Will be analyzed using an ANCOVA model containing fixed effects of treatment condition (iPAD vs. no iPAD), baseline HADS-Depression score, and a random, normally distributed error term. The data will be log-transformed prior to analysis, so all resulting inferences will be based on the geometric mean instead of the arithmetic mean.	Baseline to day 10
Secondary	Change in Profile of Mood States Short Form (POMS-SF) scores	Will be analyzed using an ANCOVA model containing fixed effects of treatment condition (iPAD vs. no iPAD), baseline POMS-SF score, and a random, normally distributed error term. The data will be log-transformed prior to analysis, so all resulting inferences will be based on the geometric mean instead of the arithmetic mean.	Baseline to day 10

External Links

•   The Jamesline