The Economic Consequences of Loneliness Among the Elderly

Study Overview
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Brief Summary
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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.

Official Title
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The Economic Consequences of Loneliness Among the Elderly

Conditions
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Loneliness

Intervention / Treatment
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* Behavioral: Phone therapy
* Behavioral: Cash transfer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 55 years of age Individuals living alone Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Phone therapy<br>Weekly phone calls by lay trained personnel to deliver problem solving therapy. | Behavioral: Phone therapy<br>* Weekly phone calls by lay trained personnel to deliver problem solving therapy.<br>|
| Experimental: Phone therapy plus cash transfer<br>Weekly phone calls by lay trained personnel to deliver problem solving therapy. Combined with a one-time cash transfer of Rs.1000. | Behavioral: Phone therapy<br>* Weekly phone calls by lay trained personnel to deliver problem solving therapy.<br>Behavioral: Cash transfer<br>* One-time cash transfer of Rs.1000.<br>|
| Experimental: Cash transfer<br>One-time cash transfer of Rs.1000. | Behavioral: Cash transfer<br>* One-time cash transfer of Rs.1000.<br>|
| No Intervention: Control<br>Control group. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Survival of elderly person | Whether still living at time of follow-up survey (0/1 variable) | Assessed at 3 weeks after intervention | 
| Survival of elderly person | Whether still living at time of follow-up survey (0/1 variable) | Assessed at 3 months after intervention | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 |