NCT05644288

Impact of the HELPeN Program on Social Isolation in Community-dwelling Elders (HELPeN)

Impact of the HELPeN Telecare Program on Social Isolation and Loneliness in Community-dwelling Elders: Randomized Control Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 84 (estimated)
• Sponsor: MARIA RUZAFA MARTINEZ · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

The main objective is to determine the effectiveness of the HELPeN Program, a 12-month telephone telenursing program for community-dwelling elderly in social isolation, evaluating the main changes in levels of social isolation, loneliness, quality of life, mental health status (depression), sleep and functional capacity, as well as changes in care management (demand for services and consumption of drugs). Methodology Two-arm parallel stratified randomized clinical trial with 12 months duration performing measurements at time 0, 3, 6, 6, 9 and 12 months. Participating subjects will be selected by nursing professionals from users of Area 3 of Health of the Region of Murcia over 65 years old, residing in the community and with a Social Isolation score \<32 (Low perceived social support with DUFSS). Randomization will be performed after stratification according to whether the subjects live alone or accompanied, with a 1:1 ratio. Given an alpha level of 0.05, an anticipated effect size of 1.58, beta power equal to 1, 42 subjects are required in each group. The intervention consists of a telephonic telenursing program HELPeN (Help eNursing) to be carried out in collaboration with the Poncemar Volunteer Bank. The control group will not receive any intervention.

Conditions

• Loneliness
• Isolation, Social

Interventions

Type	Name	Description
OTHER	Help eNursing	The proposed intervention is a telephonic telenursing program aimed at managing social isolation in the elderly, the HELPeN (Help eNursing) program. The operational part of the intervention will be carried out by volunteers nursing students from the University of Murcia enrolled in the academic years 2020-2023. To ensure homogeneity in the intervention carried out by the volunteers they will receive a 15-hour training oriented to ensure the acquisition of essential communication skills for the implementation of the intervention and to know the specific interventions of support and counseling for the elderly in social isolation. Over the 36 weeks of the HELPeN Program, each volunteer is expected to provide intervention to 2 seniors, making 1 call per week to each subject lasting approximately 30 minutes. Students will perform physical and psychosocial assessments of the elders and create individualized care plans based on each subject's needs.

Timeline

• Start date: 2022-12-01
• Primary completion: 2024-05-31
• Completion: 2025-12-31
• First posted: 2022-12-09
• Last updated: 2022-12-09

Locations

1 site across 1 country: Spain