The Economic Consequences of Loneliness Among the Elderly

Loneliness Clinical Trial

Official title:

The Economic Consequences of Loneliness Among the Elderly

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04225845
• Other study ID #: 172020
• Secondary ID: P01AG005842
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 1, 2020
• Est. completion date: December 2027

Study information

• Verified date: March 2023
• Source: National Bureau of Economic Research, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Elderly individuals across the world are increasingly living alone. However, little is known about the effects of loneliness on economic and health outcomes. The elderly living alone (i.e., in a household of size 1) will be randomized into one of two cross-randomized intervention arms or a control condition to improve older individuals' mental wellbeing as well as ability to cover basic needs, particularly in times of COVID (including health). The first intervention will focus on improving the elderly's outlook on life and relationships through problem-solving therapy (PST) delivered over the phone. The second will deliver to them a one-time cash transfer of Rs.1000, equivalent to the emergency help amount distributed to ration card holder by the government of Tamil Nadu. Each intervention will be offered on its own in each of two treatment arms, and in combination in a third. A control group will receive no intervention. Investigators will track outcomes of the elderly at 3 weeks and 3 months after the intervention.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1120
• Est. completion date: December 2027
• Est. primary completion date: December 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years and older

Eligibility

Inclusion Criteria:

• At least 55 years of age

• Individuals living alone

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Loneliness

Intervention

Behavioral:
• Phone therapy
Weekly phone calls by lay trained personnel to deliver problem solving therapy.
• Cash transfer
One-time cash transfer of Rs.1000.

Locations

Country	Name	City	State
India	JPAL SA at IFMR	Chennai	Tamil Nadu

Sponsors (3)

Lead Sponsor	Collaborator
National Bureau of Economic Research, Inc.	Abdul Latif Jameel Poverty Action Lab, National Institute on Aging (NIA)

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difficulty in performing daily activities/Functional impairment score	Participants will be asked the level of difficulty they have in doing each of the following tasks: standing for 30 minutes, walking a long distance (1km), concentrating for 10 minutes, learning a new task like getting to a new place, washing whole body, getting dressed, taking care of household activities, doing day-to-day work, dealing with people they do not know, maintaining a friendship, being emotionally affected by health problems, and joining in community activities. The scale is from 0-4, with 0 being no difficulty, 1 mild, 2 moderate, 3 severe, and 4 cannot do. The scores will be summed to create a cumulative score on a 0-48 scale.	Assessed at 3 weeks after intervention
Primary	Difficulty in performing daily activities/Functional impairment score	Participants will be asked the level of difficulty they have in doing each of the following tasks: standing for 30 minutes, walking a long distance (1km), concentrating for 10 minutes, learning a new task like getting to a new place, washing whole body, getting dressed, taking care of household activities, doing day-to-day work, dealing with people they do not know, maintaining a friendship, being emotionally affected by health problems, and joining in community activities. The scale is from 0-4, with 0 being no difficulty, 1 mild, 2 moderate, 3 severe, and 4 cannot do. The scores will be summed to create a cumulative score on a 0-48 scale.	Assessed at 3 months after intervention
Primary	Mental health	The geriatric depression index short form is used. Participants are asked yes/no questions: if they are satisfied with their lives, have dropped activities and interests, feel their life is empty, often get bored, in good spirits most of the time, afraid that something bad is going to happen to them, feel happy most of the time, often feel hopeless, prefer to stay at home, rather than going out and doing new things, have problems with memory, think it is wonderful to be alive, feel worthless, feel full of energy, feel lonely, feel their situation is hopeless, think that most people are better off than they are. Responses will be summed over these questions.	Assessed at 3 weeks after intervention
Primary	Mental health	The geriatric depression index short form is used. Participants are asked yes/no questions: if they are satisfied with their lives, have dropped activities and interests, feel their life is empty, often get bored, in good spirits most of the time, afraid that something bad is going to happen to them, feel happy most of the time, often feel hopeless, prefer to stay at home, rather than going out and doing new things, have problems with memory, think it is wonderful to be alive, feel worthless, feel full of energy, feel lonely, feel their situation is hopeless, think that most people are better off than they are. Responses will be summed over these questions.	Assessed at 3 months after intervention
Primary	Food security	Participants will be asked to report whether in the past week they had to skip or cut the size of meals in the past week.	Assessed at 3 weeks after intervention
Primary	Food security	Participants will be asked to report whether in the past week they had to skip or cut the size of meals in the past week.	Assessed at 3 months after intervention
Secondary	Seeking or receiving COVID vaccine	Participants will be asked if they received the COVID vaccine or sought it (went to the health center but there was no availability).	Assessed at 3 weeks after intervention
Secondary	Seeking or receiving COVID vaccine	Participants will be asked if they received the COVID vaccine or sought it (went to the health center but there was no availability).	Assessed at 3 months after intervention
Secondary	Loneliness	Measured using the short-form University of California, Los Angeles (UCLA) Loneliness Scale (aka ULS-4). This is a 4-item scale designed to measure one's subjective feelings of loneliness as well as feelings of social isolation. The questions are: no one really knows me well, people are around me but not with me, I feel in tune with the people around me, I can find companionship when I want it. Subjects rate each item as either O ("I often feel this way"), S ("I sometimes feel this way"), R ("I rarely feel this way"), N ("I never feel this way"). Responses are summed over the four questions and rescaled to a 0-1 scale.	Assessed at 3 weeks after intervention
Secondary	Loneliness	Measured using the short-form University of California, Los Angeles (UCLA) Loneliness Scale (aka ULS-4). This is a 4-item scale designed to measure one's subjective feelings of loneliness as well as feelings of social isolation. The questions are: no one really knows me well, people are around me but not with me, I feel in tune with the people around me, I can find companionship when I want it. Subjects rate each item as either O ("I often feel this way"), S ("I sometimes feel this way"), R ("I rarely feel this way"), N ("I never feel this way"). Responses are summed over the four questions and rescaled to a 0-1 scale.	Assessed at 3 months after intervention
Secondary	Healthcare utilization	Participants will be asked if they fell ill in the last week, and, if yes, whether they used a medical provider or pharmacy to deal with the illness (0/1).	Assessed at 3 weeks after intervention
Secondary	Healthcare utilization	Participants will be asked if they fell ill in the last week, and, if yes, whether they used a medical provider or pharmacy to deal with the illness (0/1).	Assessed at 3 months after intervention
Secondary	Survival of elderly person	Whether still living at time of follow-up survey (0/1 variable)	Assessed at 3 weeks after intervention
Secondary	Survival of elderly person	Whether still living at time of follow-up survey (0/1 variable)	Assessed at 3 months after intervention
Secondary	Social integration: non-family	This is an indicator for whether the participant talked on the phone with anyone (with the exception of children and grandchildren) in the past week (0/1 scale).	Assessed at 3 weeks after intervention
Secondary	Social integration: non-family	This is an indicator for whether the participant talked on the phone with anyone (with the exception of children and grandchildren) in the past week (0/1 scale).	Assessed at 3 months after intervention
Secondary	Social integration: family	This is an indicator for whether the participant talked on the phone with children or grandchildren in the past week (0/1 scale).	Assessed at 3 weeks after intervention
Secondary	Social integration: family	This is an indicator for whether the participant talked on the phone with children or grandchildren in the past week (0/1 scale).	Assessed at 3 months after intervention
Secondary	Cognitive function	Participants will be administered the mini mental state exam, scored on a 0-11 scale, rescaled to a 0-1 scale.	Assessed at 3 weeks after intervention
Secondary	Cognitive function	Participants will be administered the mini mental state exam, scored on a 0-11 scale, rescaled to a 0-1 scale.	Assessed at 3 months after intervention
Secondary	Consumption	Participants will be asked, for the last week, amount spent on different food items (rice, wheat, pulses, milk, spices, sugar, oil, meats, vegetables, fruits, packaged foods), medical expenses, fuel, clothing, footwear, toiletries, transportation, gifts, jewelry, and other expenses.	Assessed at 3 weeks after intervention
Secondary	Consumption	Participants will be asked, for the last week, amount spent on different food items (rice, wheat, pulses, milk, spices, sugar, oil, meats, vegetables, fruits, packaged foods), medical expenses, fuel, clothing, footwear, toiletries, transportation, gifts, jewelry, and other expenses.	Assessed at 3 months after intervention
Secondary	Health	This is a 16-point score comprised of indicators for whether the respondent faced health issues in the last week, according to the question, Did you face any health issues in the past week?, and then a follow-up in which the participant specified which health issues they faced. For each of the following (unprompted) issues they faced, one point was added to their score: cold/runny nose/cough/sore throat, fever, diabetes/hypertension, excessive fatigue, dizziness, earache, chills/shivering, diarrhoea, vomiting, bloody stool/urine, body/joint pain, fall/injury, acute emergency, breathlessness, vision/hearing/skin problems, other. Those who reported no health issues were given a score of zero.	Assessed at 3 weeks after intervention
Secondary	Health	This is a 16-point score comprised of indicators for whether the respondent faced health issues in the last week, according to the question, Did you face any health issues in the past week?, and then a follow-up in which the participant specified which health issues they faced. For each of the following (unprompted) issues they faced, one point was added to their score: cold/runny nose/cough/sore throat, fever, diabetes/hypertension, excessive fatigue, dizziness, earache, chills/shivering, diarrhoea, vomiting, bloody stool/urine, body/joint pain, fall/injury, acute emergency, breathlessness, vision/hearing/skin problems, other. Those who reported no health issues were given a score of zero.	Assessed at 3 months after intervention