NCT02816801

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable quality-of-life

Timeline
Completed

Started Jun 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

June 22, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 29, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

May 10, 2017

Status Verified

May 1, 2017

Enrollment Period

11 months

First QC Date

June 22, 2016

Last Update Submit

May 9, 2017

Conditions

Quality of Life

Outcome Measures

Primary Outcomes (1)

  • World Health Organization Quality of Life (WHOQL)-BREF

    Quality of life

    3 months

Secondary Outcomes (2)

  • Geriatric Depression Scale

    3 months

  • State-Scale of the State-Trait Anxiety Inventory (STAI-S)

    3 months

Study Arms (2)

Intervention

EXPERIMENTAL

Access to Butler-Program 2.0

Other: Butler-Program 2.0

Waitlist

NO INTERVENTION

Interventions

Butler-Program 2.0OTHER

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.

Intervention

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • age: 65 years or older
  • comprehension of German language
  • access to Internet

You may not qualify if:

  • suicidality
  • poor eyesight which makes use of intervention impossible

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Zurich

Zurich, 8050, Switzerland

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2016

First Posted

June 29, 2016

Study Start

June 1, 2016

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

May 10, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)