Feasibility of Depression Care Management by E-mail

• Sponsor: Kaiser Permanente (Other)
• Overall Status: Completed
• CT.gov ID: NCT00755235
• Collaborator: National Institute of Mental Health (NIMH) (NIH)
• Enrollment: 208
• Location: 1
• Arms: 2
• Duration (Months): 12
• Patients Per Site Per Month: 17.3

Study Details

Study Description

Brief Summary

This study will test whether an electronic system that monitors and sends messages to help people with depression could be feasible, acceptable, and potentially effective as a treatment.

Condition or Disease	Intervention/Treatment	Phase
Depression	Other: Depression care management by secure messaging	N/A

Detailed Description

Symptoms of depression, such as persistent sadness, problems sleeping, and inability to feel pleasure, interfere with the daily lives of more than 20 million Americans. Previous research indicates that telephone care management systems improve the quality and outcomes of depression care, but are too expensive to be used widely. Using secure messaging over e-mail would be more cost effective than telephone care. This study will examine whether a secure messaging care management program would be feasible, based on whether participants are willing to sign up for and continue with the program, and whether the program has a positive effect on those participants enrolled in the program.

Potential participants for this study will be contacted via e-mail, with a follow-up telephone call if they do not respond to the e-mail message. Only people who have used e-mails in the past year and who are starting antidepressant treatment will be contacted. The percentage of people contacted who enroll will be recorded.

Participation in this study will last 6 months. Participants will be randomly assigned to receive either a secure messaging care management program, based on effective telephone management programs, or their usual care with no intervention. Those receiving the secure messaging program will receive an initial welcome message and monitoring messages approximately 2, 6, and 10 weeks after treatment has begun. The monitoring messages will include structured assessments of depression severity, medication adherence, medication side effects, and barriers to continuing treatment. Participants who do not respond to monitoring messages will receive up to two e-mailed reminders. Care managers will analyze the results of monitoring messages, provide feedback and recommendations to physicians, coordinate physician follow-ups, and facilitate emergency care or specialty referrals. Care managers will also provide patients with motivation, based on semi-scripted protocols, and education concerning their disorder and treatment. Measures of the success of the study will be taken at enrollment and after 6 months of participation. Specific measurements will include the response rate of recruitment e-mails, response rate for follow-up data collection, proportion of those in the secure messaging program who complete the monitoring assessments, effects of the program on antidepressant treatment, and effects of the program on patient satisfaction.

Study Design

• Study Type: Interventional
• Actual Enrollment: 208 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Health Services Research
• Official Title: Pilot Trial of Depression Care Management by Electronic Secure Messaging
• Study Start Date: Apr 1, 2009
• Actual Primary Completion Date: Apr 1, 2010
• Actual Study Completion Date: Apr 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Participants will receive depression care management by secure messaging.	Other: Depression care management by secure messaging; Participants will receive electronic messages welcoming them and monitoring their antidepressant treatment. Care managers will use monitoring data to aid participants' physicians, coordinate physician follow-ups, facilitate emergency care, and facilitate specialty referrals. Care managers will also provide motivation and education to participants.; Other Names: online messaging email
No Intervention: 2 Participants will receive their usual care, with no additional education or care management services.

Outcome Measures

Primary Outcome Measures

1. 20-Item Symptom Checklist Depression Scale [Measured at baseline and after 6 months of treatment]

   20-item depression severity scalse adapted from longer SCL-90. Mean score ranges from 0 to 4 with scores above 1.5 indicating moderate depression.

Secondary Outcome Measures

1. Treatment Satisfaction [Measured after 6 months of treatment]

   Single item seven point scale ranging from "very satisfied" to "very dissatisfied"

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patient at Capitol Hill or Rainier clinics of Group Health Cooperative in Seattle

• New prescription of an antidepressant, defined by an interval of at least 180 days since a previous antidepressant prescription

• Indication of depression, defined by a visit diagnosis of major depressive disorder (Internal Classification of Diseases 9th Revision [ICD9] codes 296.2x or 296.3x) within 30 days of the first prescription

• Has used secure messaging, or e-mailing, at least twice in the last 12 months

Exclusion Criteria:

• Any diagnosis of psychotic disorder or bipolar disorder in the prior 2 years

• Any prescription for mood stabilizer or antipsychotic medication in the prior 2 years

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Group Health Cooperative Center for Health Studies	Seattle	Washington	United States	98101

Sponsors and Collaborators

• Kaiser Permanente
• National Institute of Mental Health (NIMH)

Investigators

• Principal Investigator: Gregory E. Simon, MD, MPH, Group Health Cooperative Center for Health Studies

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kaiser Permanente
• ClinicalTrials.gov Identifier: NCT00755235
• Other Study ID Numbers: R21MH082924; R21MH082924; DSIR 82-SEDR
• First Posted: Sep 18, 2008
• Last Update Posted: Nov 13, 2017
• Last Verified: Oct 1, 2017

• Keywords provided by Kaiser Permanente: Depression; Primary care; Effectiveness; Care management
• Additional relevant MeSH terms: Depression; Depressive Disorder

Study Results

Participant Flow

Arm/Group Title	Secure Messaging Care Management	Usual Care
Arm/Group Description	Participants will receive depression care management by secure messaging.	Participants will receive their usual care, with no additional education or care management services.
Period Title: Overall Study
STARTED	106	102
COMPLETED	104	93
NOT COMPLETED	2	9

Baseline Characteristics

Arm/Group Title	Secure Messaging Care Management	Usual Care	Total
Arm/Group Description	Participants will receive depression care management by secure messaging.	Participants will receive their usual care, with no additional education or care management services.	Total of all reporting groups
Overall Participants	106	102	208
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	96 90.6%	94 92.2%	190 91.3%
>=65 years	10 9.4%	8 7.8%	18 8.7%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	48 (9)	48 (10)	48 (9)
Sex: Female, Male (Count of Participants)
Female	76 71.7%	74 72.5%	150 72.1%
Male	30 28.3%	28 27.5%	58 27.9%
Region of Enrollment (participants) [Number]
United States	106 100%	102 100%	208 100%

Outcome Measures

1. Primary Outcome

Title	20-Item Symptom Checklist Depression Scale
Description	20-item depression severity scalse adapted from longer SCL-90. Mean score ranges from 0 to 4 with scores above 1.5 indicating moderate depression.
Time Frame	Measured at baseline and after 6 months of treatment

Outcome Measure Data

Analysis Population Description

Analysis included all participants participating in outcome assessment

Arm/Group Title	Secure Messaging Care Management	Usual Care
Arm/Group Description	Participants will receive depression care management by secure messaging.	Participants will receive their usual care, with no additional education or care management services.
Measure Participants	104	93
Mean (Standard Deviation) [units on a scale]	0.95 (0.71)	1.17 (0.81)

2. Secondary Outcome

Title	Treatment Satisfaction
Description	Single item seven point scale ranging from "very satisfied" to "very dissatisfied"
Time Frame	Measured after 6 months of treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Secure Messaging Care Management	Usual Care
Arm/Group Description	Participants will receive depression care management by secure messaging.	Participants will receive their usual care, with no additional education or care management services.
Measure Participants	104	93
Very Satisfied	56 52.8%	31 30.4%
Less than very satisfied	48 45.3%	62 60.8%

Adverse Events

Arm/Group Title	Secure Messaging Care Management		Usual Care
Arm/Group Description	Participants will receive depression care management by secure messaging.		Participants will receive their usual care, with no additional education or care management services.
All Cause Mortality
	Secure Messaging Care Management		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Secure Messaging Care Management		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/104 (0%)		0/93 (0%)
Psychiatric disorders
Suicide attempt	0/104 (0%)	0	0/93 (0%)	0
Other (Not Including Serious) Adverse Events
	Secure Messaging Care Management		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/104 (0%)		0/93 (0%)

Limitations/Caveats

Findings apply only to patients who choose to communicate by online messaging.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.