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Tailored Implementation Intervention for Managing Depressed Elderly Patients in Primary Care (TICD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01913236
Recruitment Status : Completed
First Posted : August 1, 2013
Last Update Posted : August 3, 2016
European Union
Information provided by (Responsible Party):
Sykehuset Innlandet HF

Brief Summary:

Background The prevalence of depression is high and the elderly have an increased risk of developing a chronic course. International data suggest that depression in the elderly is under-recognised, the latency before clinicians provide a treatment plan is longer, and elderly patients with depression are not offered psychotherapy to the same degree as younger patients. Although recommendations for the treatment of elderly patients with depression exist, health care professionals adhere to these recommendations to a limited degree only. Investigators conducted a systematic review to identify recommendations for managing depression in the elderly and prioritised six recommendations. Investigators identified and prioritised determinants of practice related to implementation of these recommendations in primary care, and subsequently discussed and prioritised interventions to address the identified determinants. The objective of this study is to evaluate the effectiveness of these tailored implementation interventions to implement six recommendations for the management of elderly patients with depression in primary care.

Methods/design Investigators will conduct a pragmatic cluster randomised trial comparing implementation of the six recommendations using tailored interventions with usual care. Investigators will randomize 80 municipalities into one of two groups: an intervention group, to which investigators will deliver tailored interventions to implement the six recommendations, and a control group, to which investigators will not deliver any intervention. Investigators will randomise municipalities rather than patients, individual clinicians or practices because we will deliver the intervention for the first three recommendations at the municipal level and investigators want to minimise the risk of contamination across practices for the other three recommendations. The primary outcome is the proportion of general practitioners' behaviours which are consistent with the recommendations.

Discussion This trial will investigate whether a tailored implementation approach is an effective strategy to improve collaborative care in the municipalities and health care professionals' practice towards elderly patients with depression in primary care. The effectiveness evaluation described in this protocol will be accompanied with a process evaluation exploring why and how the interventions were effective or ineffective.

Condition or disease Intervention/treatment Phase
Depression Other: Implementation intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: A Pragmatic Cluster Randomised Trial of a Tailored Intervention for Implementing Recommendations for Managing Depressed Elderly Patients in Primary Care: Protocol
Study Start Date : September 2013
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Implementation intervention
Tailored implementation intervention to address determinants of practice in primary care
Other: Implementation intervention
Investigators will provide a comprehensive package of interventions to assist health care professionals to adhere to the recommendations. The package will include support for developing a collaborative care plan in the municipality, resources for general practitioners and other health care professionals, resources for patients, their relatives and volunteers,outreach visits to general practitioners' practices and their educational groups, educational resources and web-based resources.

No Intervention: Control
Treatment as usual provided by general practitioners to elderly patients with depression

Primary Outcome Measures :
  1. General practitioners'adherence to treatment recommendations [ Time Frame: 3-6 months after end of intervention ]

Secondary Outcome Measures :
  1. Patient improvement [ Time Frame: 3-6 months after end of intervention ]
    General practitioners' assessment of improvement

  2. Patient improvement [ Time Frame: 3-6 months after end of intervention ]
    Patients' assessment of improvement from depressive and anxiety symptoms, assessment of sleep, adherence to medication, physical exercise and problem-solving abilities

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years to 100 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Home-dwelling patients aged 65 or higher, who have a diagnosis of depression, according to International Statistical Classification of Diseases and Related Health Problems, Tenth Revision

Exclusion Criteria:

Patients will be excluded if they have a diagnosis of dementia, bipolar disorder or reside in nursing homes or is assessed by their practitioner to have low life expectancy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01913236

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Knowledge Centre for the Health Services
Oslo, Norway, 0130
Sponsors and Collaborators
Sykehuset Innlandet HF
European Union
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Principal Investigator: Michel Wensing, Professor

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Sykehuset Innlandet HF Identifier: NCT01913236    
Other Study ID Numbers: 150204
258837 ( Other Grant/Funding Number: European Union Seventh Framework Program 2007-2013 )
First Posted: August 1, 2013    Key Record Dates
Last Update Posted: August 3, 2016
Last Verified: July 2013
Keywords provided by Sykehuset Innlandet HF:
Tailored implementation interventions
Primary care
Depression in the elderly
Additional relevant MeSH terms:
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Behavioral Symptoms