Lumbar Spinal Fusion - Web-based Platform Targeting Anxiety and Depression

NCT02615483 | Completed DMC

• 1 other identifier: 654902
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the present study is to investigate the effect of a Web- based Platform (WP) on anxiety and depression and health economics among patients undergoing lumbar spine fusion (LSF).

Conditions

Lumbar Spine Fusion; Anxiety; Depression

Outcome Measures

Primary Outcomes (1)

• Anxiety and Depression

  The change in anxiety and depression measures by Hospital Anxiety and Depression Scale (HADS)

  3 months after surgery

Secondary Outcomes (4)

• Functional outcome

  3, 6,12 months after surgery

• Self-perceived health status

  3, 6, 12 months after surgery

• Back and leg pain

  3, 6, 12 months after surgery

• Anxiety and Depression

  6, 12 months after surgery

Study Arms (2)

Web-based platform

EXPERIMENTAL

Access to a web-based platform

Other: Web-based platform

Control

NO INTERVENTION

Conventional

Interventions

Web-based platform OTHER

The WP is based on a conducted literature review and results form a previous study conducted in the regional context of the study. Information on the WP is animated based on the current literature stating that educative animation video optimises patients' acquisition of knowledge. The intention is to offer the patients the advantages in gaining knowledge in familiar surroundings and at a pace matching their needs and wishes. The WP contains animated and written information mirroring the course of treatment, frequently asked questions and answers, it contains animated training support, a diary in order to keep track of training and development of pain and finally a social feature, a web-café.

Web-based platform

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who are going to have a one-three level instrumented Lumbar Spinal Fusion

You may not qualify if:

• Age below 18, known psychiatric disorder, prior LSF, as the success rates of re-operations are found as low as 35%, inability to communicate in Danish and finally patients with no internet connection.

Sponsors & Collaborators

• Central Jutland Regional Hospital: lead

Study Sites (1)

Centre og Elective Surgery, Regional Hospital Silkeborg

Silkeborg, 8600, Denmark

Location

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Claus V. Nielsen, professor

  Institute of Publich health, Aarhus University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D. - Student

Study Record Dates

• First Submitted: November 20, 2015
• First Posted: November 26, 2015
• Study Start: November 1, 2015
• Primary Completion: August 1, 2018
• Study Completion: March 1, 2019
• Last Updated: August 30, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)