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

Loneliness Clinical Trial

— HELPeN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05644288
• Other study ID #: PI21/00984
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: December 2022
• Source: Universidad de Murcia
• Contact: María J Hernández-López, RN, MsC
• Phone: +34 968489191
• Email: mariaj.hernandez34[@]carm.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: December 31, 2025
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• score < 32 (Low perceived social support with the DUFSS scale)

• Residence in the community

Exclusion Criteria:

• Severe cognitive impairment (8-10 errors on the Pfeiffer test)

• Non Spanish speakers

• Failure to consent to the study

Related Conditions & MeSH terms

• Isolation, Social
• Loneliness

Intervention

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.

Locations

Country	Name	City	State
Spain	Healthcare Area III. Region of Murcia	Lorca	Murcia

Sponsors (3)

Lead Sponsor	Collaborator
MARIA RUZAFA MARTINEZ	Fundación Poncemar, Instituto de Salud Carlos III

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Loneliness	Name of the measurement: Loneliness; Definition: Loneliness is the result of a cognitive evaluation where there are discrepancies between the social relationships that people desire and those that they really have.; Measuremente tool: UCLA Loniness Scale. Developed by psychologist Daniel Russell (1996), the UCLA Loneliness Scale (Version 3) is a 20-item measure that assesses how often a person feels disconnected from others.; Unit of measure: Indicence of loneliness	9 months
Primary	Social isolation	Name of the measurement: Social isolation; Definition: Disengagement from social relationships, connections with institutions or community involvement.; Measurement tool: DUKE-UNC Functional Social Support questionnaire(DUFSS). A 14-item, self-administered, multidimensional, functional social support questionnaire.; Unit of measure: Incidence of social isolation	9 months
Secondary	Phisycal function	Name of the measurement: Phisycal function; Definition: The level of functional independence of patients with neuromuscular and musculoskeletal pathologies; Measurement tool: Barthel Index for Activities of Daily Living. Scale used to measure performance in activities of daily living (ADL). Ten variables describing ADL and mobility are scored, a higher number being a reflection of greater ability to function independently following hospital discharge.; Unit of measure: % of subjects "able to live independently"; "minimally dependent"; "partially dependent"; "very dependent"; "total dependece"	9 months
Secondary	Depression	Name of the measurment: Depression; Definition: Depression is a common but serious mood disorder. It causes severe symptoms that affect how you feel, think, and handle daily activities, such as sleeping, eating, or working.; Measurement tool: Geriatric Depression Scale (GDS). The original scale consists of 30 dichotomous items (Yes/No), and direct scoring, between 0 and 30.; Unit of measure: Incidence of depression and mean punctuation in the GDS scale	9 months
Secondary	Mental status	Name of the measurement: Mental status; Definition: Measuremente tool: Short portable mental status questionnaire (SPMSQ) (Pfeiffer's test). It is a brief questionnaire composed of ten questions that measure the degree of cognitive impairment. Evaluates cognitive impairment for the purpose of screening for dementia. Heteroapplied.; Unit of measure: Incidence of cognitive impairment and % of subject with "intact intellectual functioning"; "intact intellectual functioning"; "moderate intellectual impairment" and "severe intellectual impairment"	9 months
Secondary	Anxiety	Name of the measuremente: Anxiety; Definition: Generalized anxiety disorder (GAD) include clearly excessive, uncontrollable, and often irrational anxiety and worry of a duration of at least 6 months; Measuremente tool: 7-item Generalized Anxiety Disorder Scale (GAD-7). It is a 7 items self-report scale designed to identify probable cases of GAD.; Unit of measure: % of subjects with "minimal anxiety"; "mild anxiety"; "severe anxiety"	9 months
Secondary	Health Related Quality of life	Name of the measurement: Health Related Quality of life; Definition: It encompass those aspects of overall quality of life that can be clearly shown to affect health-either physical or mental; Measuremente tool: European Quality of Life-5 Dimension (EQ-5D). It can be used at the individual level to monitor a patient's health status over time. The EQ-5D instrument consists of 2 parts - the EQ-5D descriptive system and the Visual Analog Scale (VAS). The EQ-5D descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. In the VAS the individual scores his or her health between two extremes, 0 and 100, the worst and the best state of health imaginable.; Unit of measure: % of subjects reporting health problems by level in each dimension. Mean punctuation of the VAS scale.	9 months
Secondary	Health assistance	Name of the measurement: Health assistance; Definition: Health care provided to a patient including: hospitalization, face-to-face or telephone consultation, home care, visit to emergency department and the professional providing the care.; Measuremente tool: these information will be collected from electronic record of the patients; Unit of measure:% of subjects requiring health assistance: hospitalization, face-to-face or telephone consultation, home care, visit to emergency department and the professional providing the care.	9 months
Secondary	Drugs	Name of the measurement: Consumption of drugs; Definition: the prescription or increase in daily dosage, according to the anatomical-therapeutic classification (ATC) of the WHO, of the following drugs will be recorded: Psycholeptics, Psychoanaleptics, Analgesics, Muscle relaxants and Other drugs.; Measuremente tool: prescriptions will be collected from electronic record of the patients; Unit of measure: % of subjects taking Psycholeptics, Psychoanaleptics, Analgesics, Muscle relaxants and Other drugs.	9 months