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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Venous Leg Ulcer; Social Interaction
• Intervention / Treatment: Other: Social leg program

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.

• Study Type: Interventional
• Enrollment (Anticipated): 268
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sebastian E Probst, Prof Dr; Phone Number: 5709 022 3885600; Email: sebastian.probst@hesge.ch

Study Locations

• Switzerland
  • GE
    • Carouge, GE, Switzerland, 1227
      • IMAD
      • Contact: Stéphane Coffre, RN; Phone Number: 022 420 22 52; Email: stephane.coffre@imad-ge.ch
    • Onex, GE, Switzerland, 1213
      • Cité Génération Maison de santé

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; 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.
Other: Social leg Program; 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.	Other: Social leg program; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to therapy	Adherence to therapy, including physical activity, leg elevation, ankle exercises, wearing compression stockings, will be measured in minutes	six months
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	six months
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.	six months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	six months
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.	six months
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.	six months
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.	six months
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.	six months
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.	six months

Collaborators and Investigators

• Sponsor: School of Health Sciences Geneva
• Investigators: Principal Investigator: Sebastian E Probst, Prof Dr, HES-SO University of Applied Sciences and Arts Western Switzerland

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2023
• Primary Completion (Anticipated): March 30, 2025
• Study Completion (Anticipated): August 31, 2025

Study Registration Dates

• First Submitted: April 28, 2020
• First Submitted That Met QC Criteria: April 28, 2020
• First Posted (Actual): April 30, 2020

Study Record Updates

• Last Update Posted (Actual): January 27, 2023
• Last Update Submitted That Met QC Criteria: January 26, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: recurrence; education; leg club
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Skin Ulcer; Varicose Veins; Ulcer; Leg Ulcer; Varicose Ulcer
• Other Study ID Numbers: social leg program

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No