The Butler-Program 2.0: An Internet Platform for Elderly | NCT02816801

Studies
The Butler-Program 2.0: An Internet Platform for Elderly

NCT02816801

Sponsor

University of Zurich

Status

Completed

Last Update Posted

May 10, 2017Actual

Enrollment

27Actual

Phase

Not Applicable

Conditions

Quality of Life

Interventions

Butler-Program 2.0

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2016

Primary Completion Date

May 2017Actual

Completion Date

May 2017Actual

First Submitted Date

Jun 22, 2016

First Submission Date that Met QC Criteria

Jun 28, 2016

First Posted Date

Jun 29, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 9, 2017

Last Update Posted Date

May 10, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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).

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

27Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention	Experimental	Access to Butler-Program 2.0	Other: Butler-Program 2.0
Waitlist	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Butler-Program 2.0	Other	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
World Health Organization Quality of Life (WHOQL)-BREF	Quality of life	3 months

Secondary Outcomes

Measure	Description	Time Frame
Geriatric Depression Scale	Depression	3 months
State-Scale of the State-Trait Anxiety Inventory (STAI-S)	Anxiety	3 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Zurich		Zurich		8050	Switzerland

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided