NCT02398812

Brief Summary

The objective of this pragmatic multi-center randomized controlled trial is to test the effectiveness of interprofessional medication assessment in older patients needing home care due to their diseases or decreased functional capacity in primary care. The main hypothesis is that intervention has a positive impact on functional capacity and for rational and safe use of medicines.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
514

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 13, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 26, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

June 13, 2016

Status Verified

June 1, 2016

Enrollment Period

1.3 years

First QC Date

March 13, 2015

Last Update Submit

June 10, 2016

Conditions

MultimorbidityPolypharmacy

Outcome Measures

Primary Outcomes (5)

  • Functional capacity IADL (Instrumental Activities of Daily Living)

    at 6 months from baseline

  • Functional capacity ADL (Activities of daily living;KATZ)

    at 6 months from baseline

  • Functional capacity TUG (Timed up and go)

    at 6 months from baseline

  • Functional capacity MMSE ( Mini-mental state examination)

    at 6 months from baseline

  • Functional capacity GDS (Geriatric Depression Scale)-15

    at 6 months from baseline

Secondary Outcomes (6)

  • Use of health care services

    at 6 and 12 months from baseline

  • Need of services delivered to home

    at 6 and 12 months from baseline

  • Number of medicines

    at 6 and 12 months from baseline

  • Quality of medicines

    at 6 and 12 months from baseline

  • Cost of medicines

    at 6 and 12 months from baseline

  • +1 more secondary outcomes

Study Arms (2)

Active comparator

ACTIVE COMPARATOR

In addition to usual care, participants allocated to intervention group will receive medication assessment and treatment plan based on it

Other: Medication assessment and treatment plan based on it

Usual care

NO INTERVENTION

Usual care (reference group).

Interventions

Medication assessment and treatment plan based on itOTHER

Intervention * Phase I: A medication assessment conducted by an interprofessional team including nurse, pharmacist and physician. The assessment is based on current medication list and basic information cathered by nurse. * Phase II: This phase is needed if the assessment cannot be conducted safely without physical examination conducted by physician. The comprehensive interprofessional assessment takes place after the clinical examination conducted by home care physician.

Active comparator

Eligibility Criteria

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

You may qualify if:

  • Home dwelling ≥65 years-old persons registered to public home care services and who
  • have had dizziness, orthostatic hypotension or have fallen or
  • use at least six medicines

You may not qualify if:

  • Home care is not responsible for patient's medication, for example due to severe chronic illness (for example severe renal insufficiency or cancer with active treatment in secondary or tertiary care).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Welfare district of Forssa

Forssa, FI 30100, Finland

Location

Selänne Basic Health Care District

Haapajärvi, FI 85800, Finland

Location

Juva Health Care

Juva, FI-51900, Finland

Location

City of Lahti, home care

Lahti, FI-15100, Finland

Location

Eastern Savo Hospital District

Savonlinna, FI-57100, Finland

Location

Related Publications (1)

  • Auvinen K, Voutilainen A, Jyrkka J, Lonnroos E, Mantyselka P. Interprofessional medication assessment among home care patients: any impact on functioning? Results from a randomised controlled trial. BMC Geriatr. 2020 Oct 6;20(1):390. doi: 10.1186/s12877-020-01796-1.

    PMID: 33023497DERIVED

Study Officials

  • Pekka Mäntyselkä, MD

    Professor

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

March 13, 2015

First Posted

March 26, 2015

Study Start

February 1, 2015

Primary Completion

June 1, 2016

Study Completion

December 1, 2018

Last Updated

June 13, 2016

Record last verified: 2016-06

Locations

FI(5)