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The Impact of Frequenting a Social Leg Program on Therapeutic Adherence and Venous Leg Ulcer Wound Healing Outcomes (legclub)

Primary Purpose

Venous Leg Ulcer, Social Interaction

Status
Not yet recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Social leg program
Sponsored by
School of Health Sciences Geneva
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Venous Leg Ulcer focused on measuring leg club, education, recurrence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18 years or older,
  • with an existing diagnosed open VLU,
  • an ulcer surface <2 cm2 or having a healed VLU,
  • proficiency in the French language

Exclusion Criteria:

- Valid informed consent is not or cannot be given

Sites / Locations

  • IMAD
  • Cité Génération Maison de santé

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Other

Arm Label

Control

Social leg Program

Arm Description

Usual care for participants with existing VLU in the CG is defined as visiting the outpatient wound clinic/visits by the community care nurse as prescribed by the physician. Wound healing measurement, therapeutic adherence measurement, wound recurrence measurement, and questionnaires will be provided by the institute's nurses.

Usual care as described for the CG will also be provided to the IG. Wound healing measurement, therapeutic adherence measurement, wound recurrence measurement, and questionnaires will be provided by the institute's nurses. After baseline data collection (T0) and random allocation to the intervention group, this usual care will be enhanced by frequenting a social leg program.

Outcomes

Primary Outcome Measures

Adherence to therapy
Adherence to therapy, including physical activity, leg elevation, ankle exercises, wearing compression stockings, will be measured in minutes
Wound healing
Measurement of the impact of a social leg program on the relative reduction (in percent) of wound size in patients with VLU. Wound size will be measured using WoundWorks® imaging device
Wound recurrence
Measurement of the impact of a social leg program on absolute number of participants experiencing a recurrence (in percent) within six months over number of participants who had a healed VLU.

Secondary Outcome Measures

Wound Assessment
Wound will be evaluated in terms of exudative status, smell, infection status and pain felt. The TIME strategy (T = tissue removal; I = infection control; M = moisture balance; E = edge advancement) proposed by the European Wound Management Association will be applied
Self care
Self-care score will be evaluated using the validated self care questionnaire (Venous Leg Ulcer Self-Efficacy Tool); values: minimum (0) and maximum (300); higher scores mean a better outcome.
Depression
Depression score will be evaluated using the validated geriatric depression scale questionnaire; values: minimum (0 ) and maximum (15); lower scores mean a better outcome.
Multidimensional complexity
Multidimensional complexity will be evaluated using the validated questionnaire (multidimensional complexity assessment tool, COMID): values: minimum (0 ) and maximum (30); higher scores mean a better outcome.
General nutritional status
General nutritional status of patients will be measured using the MNA® questionnaire, a validated assessment tool that identifies people malnourished or at risk of malnutrition; values: minimum ( 0) and maximum (14); higher scores mean a better outcome.
Patient Satisfaction
Patient satisfaction will be measured using the validated Patient Benefit Index (PBI) questionnaire; values: minimum (0 ) and maximum (4); higher scores mean a better outcome.

Full Information

First Posted
April 28, 2020
Last Updated
January 26, 2023
Sponsor
School of Health Sciences Geneva
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1. Study Identification

Unique Protocol Identification Number
NCT04370106
Brief Title
The Impact of Frequenting a Social Leg Program on Therapeutic Adherence and Venous Leg Ulcer Wound Healing Outcomes
Acronym
legclub
Official Title
The Impact of Frequenting a Social Leg Program on Therapeutic Adherence and Venous Leg Ulcer Wound Healing Outcomes: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2023 (Anticipated)
Primary Completion Date
March 30, 2025 (Anticipated)
Study Completion Date
August 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
School of Health Sciences Geneva

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Background and rationale: Venous leg ulcers (VLU) are slow healing wounds with a recurrence rate up to 70% and a 60% risk of becoming chronic. Currently the Swiss health care system does not take in consideration social and educational needs and support for VLU patients who transition from acute care (hospital care, outpatient care) to home based self-care. To fill this gap, this study proposes to create the Social Legs Program (SLP). Overall objectives: The objectives of the proposed study are to evaluate the impact of a frequented SLP for patients with VLU in terms of their therapeutic adherence and wound healing outcomes (wound size and wound recurrence). Methodology of the planned study: A randomized controlled trial with 268 participants in three Swiss French institutions is proposed. Expected results and impact: The findings of this study will generate new knowledge about support and care management of persons with VLU who transition between acute care settings and home care settings. The findings will contribute to the evidence base of clinical practice guidelines for the care of patients with VLU.
Detailed Description
Background and rationale: Venous leg ulcers (VLU) are slow healing wounds with a recurrence rate up to 70% and a 60% risk of becoming chronic. Signs and symptoms such as pain or exudate are not only a burden on those affected but also on the health care system and society in general. The estimated VLU prevalence in the general population is 3%. Treatment cost for VLU is estimated to be 4% of overall health expenditure. Current therapeutic approaches are multifaceted, focus on reducing wound size as well as preventing ulcer recurrence. Depending on the severity of the VLU treatment/care occurs in the hospital setting, outpatient setting or community setting. Currently the Swiss health care system does not take in consideration social and educational needs and support for VLU patients who transition from acute care (hospital care, outpatient care) to home based self-care. To fill this gap, this study proposes to create the Social Legs Program (SLP). This program is based on the existing Leg Club (LC) community model in the United Kingdom (UK) and will be adapted for the Swiss context. The SLP is designed to provide an environment for social interaction, peer and nursing/professional support, information sharing and personal involvement. Participation in the SLP will address the need for social and educational support in this patient group and will improve therapeutic adherence and result in enhanced wound healing as well as a reduction of the wound recurrence rate. Overall objectives: The objectives of the proposed study are to evaluate the impact of a frequented SLP for patients with VLU in terms of their therapeutic adherence and wound healing outcomes (wound size and wound recurrence). Specific aims: The impact of the intervention will be measured in terms of therapeutic adherence and wound healing outcomes as well as multidimensional complexity, wound assessment, patient satisfaction, depression, general nutrition, mobility and quality of sleep. In addition, the incidence of complications (re-hospitalizations) will be measured (frequency and cost). Methodology of the planned study: A randomized controlled trial with 268 participants in three Swiss French institutions is proposed. The study participants will be consecutive patients of the participating clinics who fulfill the inclusion criteria. Wound care will be performed according to the institutions standard clinical practice guidelines. Allocation to the intervention group (IG) or the control group (CG) will be concealed. The intervention will consist in participating in the SLP. The social program will provide patients with an opportunity to exchange and learn about the prevention measures such as the use of compression bandages, and how to prevent recurrences, and enhance healing outcomes. A study nurse, who will not be identical to the nurse in charge of the control group, will supervise this group. Due to the intervention being a social program, the study cannot be blinded for either the participants or the staff performing the intervention. The sample size assumptions are based on an adjusted (Bonferroni) two-sided alpha level of 0.05, power of 0.8, and clinically relevant effect sizes and a loss to follow up of 20%. Univariate and bivariate analysis will be conducted according to the data level. Expected results and impact: The findings of this study will generate new knowledge about support and care management of persons with VLU who transition between acute care settings and home care settings. The findings will contribute to the evidence base of clinical practice guidelines for the care of patients with VLU. Additionally, it is in alignment with the National Strategy on the Prevention of Non-Communicable Diseases 2017 - 2024 establishing prevention work for people with enhanced risks and chronic conditions reinforcing a better social integration.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Leg Ulcer, Social Interaction
Keywords
leg club, education, recurrence

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
268 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Usual care for participants with existing VLU in the CG is defined as visiting the outpatient wound clinic/visits by the community care nurse as prescribed by the physician. Wound healing measurement, therapeutic adherence measurement, wound recurrence measurement, and questionnaires will be provided by the institute's nurses.
Arm Title
Social leg Program
Arm Type
Other
Arm Description
Usual care as described for the CG will also be provided to the IG. Wound healing measurement, therapeutic adherence measurement, wound recurrence measurement, and questionnaires will be provided by the institute's nurses. After baseline data collection (T0) and random allocation to the intervention group, this usual care will be enhanced by frequenting a social leg program.
Intervention Type
Other
Intervention Name(s)
Social leg program
Intervention Description
Usual care as described for the CG will also be provided to the IG. Wound healing measurement, therapeutic adherence measurement, wound recurrence measurement, and questionnaires will be provided by the institute's nurses. After baseline data collection (T0) and random allocation to the intervention group, this usual care will be enhanced by frequenting a social leg program.
Primary Outcome Measure Information:
Title
Adherence to therapy
Description
Adherence to therapy, including physical activity, leg elevation, ankle exercises, wearing compression stockings, will be measured in minutes
Time Frame
six months
Title
Wound healing
Description
Measurement of the impact of a social leg program on the relative reduction (in percent) of wound size in patients with VLU. Wound size will be measured using WoundWorks® imaging device
Time Frame
six months
Title
Wound recurrence
Description
Measurement of the impact of a social leg program on absolute number of participants experiencing a recurrence (in percent) within six months over number of participants who had a healed VLU.
Time Frame
six months
Secondary Outcome Measure Information:
Title
Wound Assessment
Description
Wound will be evaluated in terms of exudative status, smell, infection status and pain felt. The TIME strategy (T = tissue removal; I = infection control; M = moisture balance; E = edge advancement) proposed by the European Wound Management Association will be applied
Time Frame
six months
Title
Self care
Description
Self-care score will be evaluated using the validated self care questionnaire (Venous Leg Ulcer Self-Efficacy Tool); values: minimum (0) and maximum (300); higher scores mean a better outcome.
Time Frame
six months
Title
Depression
Description
Depression score will be evaluated using the validated geriatric depression scale questionnaire; values: minimum (0 ) and maximum (15); lower scores mean a better outcome.
Time Frame
six months
Title
Multidimensional complexity
Description
Multidimensional complexity will be evaluated using the validated questionnaire (multidimensional complexity assessment tool, COMID): values: minimum (0 ) and maximum (30); higher scores mean a better outcome.
Time Frame
six months
Title
General nutritional status
Description
General nutritional status of patients will be measured using the MNA® questionnaire, a validated assessment tool that identifies people malnourished or at risk of malnutrition; values: minimum ( 0) and maximum (14); higher scores mean a better outcome.
Time Frame
six months
Title
Patient Satisfaction
Description
Patient satisfaction will be measured using the validated Patient Benefit Index (PBI) questionnaire; values: minimum (0 ) and maximum (4); higher scores mean a better outcome.
Time Frame
six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years or older, with an existing diagnosed open VLU, an ulcer surface <2 cm2 or having a healed VLU, proficiency in the French language Exclusion Criteria: - Valid informed consent is not or cannot be given
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sebastian E Probst, Prof Dr
Phone
022 3885600
Ext
5709
Email
sebastian.probst@hesge.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sebastian E Probst, Prof Dr
Organizational Affiliation
HES-SO University of Applied Sciences and Arts Western Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
IMAD
City
Carouge
State/Province
GE
ZIP/Postal Code
1227
Country
Switzerland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stéphane Coffre, RN
Phone
022 420 22 52
Email
stephane.coffre@imad-ge.ch
Facility Name
Cité Génération Maison de santé
City
Onex
State/Province
GE
ZIP/Postal Code
1213
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No

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The Impact of Frequenting a Social Leg Program on Therapeutic Adherence and Venous Leg Ulcer Wound Healing Outcomes

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