- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02816801
The Butler-Program 2.0: An Internet Platform for Elderly
May 9, 2017 updated by: University of Zurich
In this study, effectiveness of an internet based intervention (Butler 2.0) for elderly is tested.
Participants (n= 60) will be randomly assigned to two different groups (intervention vs. waitlist).
Outcomes in terms of loneliness and quality of life will be assessed at pre-, post (6 weeks) and follow-up (3 months).
Study Overview
Detailed Description
Elderly people (age 65+ ) in Zurich will have access to the Butler program 2.0.
Butler 2.0 has been designed for elderly with little experience in the use of computers.
Several means of communication such as e-mail, video conferencing, chat and a blog are united on this platform.
Furthermore, relaxation exercises are offered in the form of virtual walks.
Study Type
Interventional
Enrollment (Actual)
27
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Zurich, Switzerland, 8050
- University of Zurich
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- age: 65 years or older
- comprehension of German language
- access to Internet
Exclusion Criteria:
- suicidality
- poor eyesight which makes use of intervention impossible
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Waitlist
|
|
|
Experimental: Intervention
Access to Butler-Program 2.0
|
Internet based intervention for elderly, in which they learn how to use e-mail, video conferencing and a blog, in addition to virtual relaxation exercises.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
World Health Organization Quality of Life (WHOQL)-BREF
Time Frame: 3 months
|
Quality of life
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Geriatric Depression Scale
Time Frame: 3 months
|
Depression
|
3 months
|
|
State-Scale of the State-Trait Anxiety Inventory (STAI-S)
Time Frame: 3 months
|
Anxiety
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2016
Primary Completion (Actual)
May 1, 2017
Study Completion (Actual)
May 1, 2017
Study Registration Dates
First Submitted
June 22, 2016
First Submitted That Met QC Criteria
June 28, 2016
First Posted (Estimate)
June 29, 2016
Study Record Updates
Last Update Posted (Actual)
May 10, 2017
Last Update Submitted That Met QC Criteria
May 9, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- Butler
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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